european biotechnology innovation system (ebis)€¦ · european biotechnology innovation system...

European Biotechnology Innovation System (EBIS)

National Case Study of Austria

Project EU - SOE1-CT-1117

Barbara BaierErich Griessler

Renate Martinsen

March 2001

Institut für Höhere Studien (IHS), WienInstitute for Advanced Studies, Vienna

The EBIS-Team for Austria:

Renate Martinsen (project director)

Barbara Baier *

Erich Griessler **

With assistance of:

Susanne Pernicka ***

Lydia Sattler ****

* responsible for the Agro-Food Sector (Chapter 3); jointly responsible for

Chapter 1 and 5

** responsible for the Biopharmaceutical Sector (Chapter 2) and the Equipment and

Supplies Sector (Chapter 4); jointly responsible for Chapter 1 and 5

*** responsible for the contribution on patents and patent laws in biotechnology

**** technical expert on biotechnology

Institut für Höhere Studien Stumpergasse 56 A - 1060 Wien AUSTRIA

Contents

1 Background to the Case Studies....................................................1

1.1 General Introduction to Characteristics of the Country ............................................. 1

1.1.1 Public Acceptance of Biotechnology .......................................................................... 4

1.1.2 Specific Characteristics of Austria Which May Affect Development

of Biotechnology ....................................................................................................... 9

1.2 General Government Policy for Biotechnology ....................................................... 13

1.2.1 Overview of the General Government Policy for Biotechnology since 1980 ........... 13

1.2.2 Policies for Public Sector Research and Technology Transfer ............................... 16

1.2.3 Industrial Policy ....................................................................................................... 16

1.2.4 Intellectual Property Rights (IPR) Policy and Similarity/Difference to EC-Policy .... 19

1.2.5 Policy to Promote Public Acceptance of Biotechnology........................................... 19

1.2.6 Policy to Encourage Interaction Between the Various Networks ............................. 21

1.3 The Science Base.................................................................................................... 21

1.3.1 Amount of Funds Available for Biotechnology Research 1994-1998

and Main Funders .................................................................................................... 23

1.3.2 Funding Regime for the Science Base and Its Effect on Academic Interest in

Interacting with Industry .......................................................................................... 33

1.3.3 Rules for Academic Intellectual Property and Employment Conditions

and the Effect on Commercialisation ...................................................................... 34

1.3.4 Post-Graduate Courses Available in Higher Education .......................................... 36

1.3.5 Personnel Involved in Doctoral Training and Number of Awarded PhDs

in the Period 1994-1998........................................................................................... 36

1.4 Other Issues............................................................................................................. 37

1.4.1 Regulation of Bio-/Gene Technology ...................................................................... 37

1.4.2 Investment Capital .................................................................................................. 45

2 Biopharmaceuticals .....................................................................49

2.1 The Science Base.................................................................................................... 52

2.1.1 Public Funding Organisations .................................................................................. 52

2.1.2 Research Organisations .......................................................................................... 52

2.1.3 Share of Total Biotechnology Research Funds Allocated 1994-1998 ...................... 54

2.1.4 Special Programmes for University/Industry Research Collaboration ..................... 55

2.1.5 National Involvement in Framework Programmes................................................... 56

2.2 Industrial Structure ................................................................................................... 56

2.2.1 Firm Characteristics ................................................................................................. 57

2.2.2 Dominance of National, European, US or Rest of World Owned Firms................... 58

2.2.3 Total Turnover of Sector and Source........................................................................ 58

2.2.4 Main Geographic Market.......................................................................................... 58

2.2.5 Source of Technology............................................................................................... 58

2.2.6 Main Suppliers to the Sector .................................................................................... 59

2.2.7 Research Collaborations.......................................................................................... 59

2.2.8 Business Interest Non-Government Organisations (BINGOs) ................................. 60

2.3 Consumer Attitudes and Market Demand ................................................................ 60

2.3.1 Market Size and Specific Characteristics................................................................. 60

2.3.2 Regulation Policy ..................................................................................................... 65

2.3.3 Public Interest Non-Government Organisations (PINGOs)...................................... 66

2.3.4 Case Study of Controversy: Xenotransplantation .................................................... 66

2.4 Prospects for the Sector........................................................................................... 79

3 The Agro-Food Sector.................................................................. 83

3.1 The Science Base.................................................................................................... 85

3.1.1 Public Funding Organisations .................................................................................. 85

3.1.2 Research Organisations........................................................................................... 85

3.1.3 Share of Total Biotechnology Research Funds Allocated 1994-1998 ...................... 88

3.1.4 Special Programmes for University/Industry Research Collaboration...................... 89

3.1.5 National Involvement in Framework Programmes ................................................... 89

3.2 Industrial Structure ................................................................................................... 90

3.2.1 Firm Characteristics ................................................................................................. 91

3.2.2 Dominance of National, European, US or Rest of World Owned Firms................... 94

3.2.3 Total Turnover of Sector and Source........................................................................ 94

3.2.4 Main Geographic Market.......................................................................................... 95

3.2.5 Source of Technology............................................................................................... 95

3.2.6 Main Suppliers to the Sector .................................................................................... 95

3.2.7 Collaborations with PSR .......................................................................................... 95

3.2.8 Collaborations with Other Firms............................................................................... 95

3.2.9 Business Interest Non-Government Organisations (BINGOs) ................................. 96

3.3 Consumer Attitudes and Market Demand ................................................................ 97

3.3.1 Market Size and Specific Characteristics................................................................. 97

3.3.2 Regulation Policy ..................................................................................................... 99

3.3.3 Public Interest Non-Government Organisations (PINGOs)...................................... 99

3.3.4 Case Study of Controversy: GM Crops .................................................................... 99

3.4 Prospects for the Sector......................................................................................... 115

4 Equipment and Supplies ............................................................119

4.1 The Science Base...................................................................................................119

4.2 Industrial Structure..................................................................................................119

4.3 Consumer Attitudes and Market Demand.............................................................. 121

4.4 Prospect for the Sector .......................................................................................... 122

5 Comparing the Three Sectors ...................................................125

5.1 Biotechnology in Austria: A Summary of Key-Indicators ........................................ 125

5.2 Summary of the Three Biotechnology Sectors in Austria....................................... 129

5.2.1 Biopharmaceutical Sector ...................................................................................... 129

5.2.2 Agro-Food Sector................................................................................................... 130

5.2.3 Equipment and Supplies Sector............................................................................. 132

5.3 Main Similarities and Differences........................................................................... 133

5.4 Theoretical Conclusions......................................................................................... 134

6 Appendix ....................................................................................137

Appendix 1: Tables ...................................................................................................................... 137

Appendix 2: Forms of Direct Democracy in Austria..................................................................... 150

Appendix 3: Regulatory Framework for Bio-/Gene technology ................................................... 152

Appendix 4: List of Interview Partners ......................................................................................... 156

Appendix 5: References .............................................................................................................. 159

Appendix 6: List of Abbreviations ................................................................................................ 166

List of Tables

Table 1: Overview on Selected Indicators of Austria 2Table 2: Comparison between Europe and Austria in Selected Risk-Domains 5Table 3: Two Main Clusters of Countries with Respect to Biotechnological

Risk-Perception and Acceptance 6Table 4: Results of the Popular Initiative on Gene Technology in Austria 8Table 5: The Exhibition "gentechnik pro&contra" across Austrian Cities 19Table 6: Number of Institutes by Organisations 22Table 7: Number of Institutes by Research Areas 22Table 8: Research Areas by Personnel 22Table 9: Summary of the Public Funding of Biotechnology in Austria 1994-1998 25Table 10: FFF Biotechnology Funding 1994-1998 27Table 11: ÖNB Biotechnology Funding 1994-1998 31Table 12: Number of Masters 1994-1998 at Relevant University Institutes in the

Biotech Sector 36Table 13: Number of PhDs 1994-1998 at Relevant University Institutes in the

Biotech Sector 37Table 14: Bio-/Gene Technology Regulation in Austria 38Table 15: European Authorization Procedures with Regard to the Placement

on the Market of GMOs 40Table 16: Responsibilities of Authorities 43Table 17: Stage Distribution of Investment of Private Equity in Austria in 1998 47Table 18: Research Institutes Active in Biopharmaceutical Research by Location 53Table 19: Number of Institutes by Number of Researchers Dedicated to

Biopharmaceuticals (1999) 54Table 20: Number of First-University Absolvents and PhDs in Bio-Pharmaceuticals

in the Responding Institutes (1994-1998) 54Table 21: National Involvement in Framework Programmes Relevant

to Biotechnology 56Table 22: Number of Firms Dedicated to Biopharmaceuticals by Number of

Employees (1999) 57Table 23: Number and Origin of R&D Co-operations of Responding Firms

with PSR 59Table 24: Number and Origin of R&D Co-operations of Responding Firms

with Other Firms 59Table 25: Pharmaceuticals for Human Medicine by Production Method

1982-July 1997 62Table 26: Number of Prescriptions and Associated Expenses of Health Insurance

Companies for Pharmaceuticals 1990-1996 63Table 27: Average Expenses of Health Insurance Companies per Prescription 65Table 28: Number of Transplantations of Selected Organs in Selected European

Countries per Million Population (1998) 67Table 29: Xenotransplantation – Lines of Argument 75Table 30: Technological State of Gene Technology in Food Production 84Table 31: Number and Location of Public Sector Research Institutes 85Table 32: National Involvement in the 4th Framework Programme FAIR 1994-1998 89

Table 33: General Overview on Responding Firms Active in the Equipmentand Supplies Sector 120

Table 34-1: Biotechnology in Austria: A Summary of Key-Indicators(Science Base) 126

Table 34-2: Biotechnology in Austria: A Summary of Key-Indicators(Industrial Structure) 127

Table 34-3: Biotechnology in Austria: A Summary of Key-Indicators(Public Acceptance) 128

Table 35: Comparison of Four Approaches to Technological Developmentby Several Selected Categories 135

Table 36: Relevance of Major Findings in the Austrian Case-Study for theFour Approaches to Technological Development 136

List of Tables in Appendix 1

Table 1: Public Attitudes Towards Bio-/Gene Technology. ComparisonAustria 1994, European Union 1993 and Norway 1993 137

Table 2: Public Attitudes Towards Bio-/Gene Technology. ComparisonAustria and European Union 1996 139

Table 3: Biotechnological Research Areas of Relevant Research Institutesin the Agro-Food Sector 140

Table 4: Number of Researchers in 1998 in Relevant Research Institutesin the Agro-Food Sector (Full Time Equivalent) 141

Table 5: Number of Masters (First-University Absolvents) and PhDs(Second-University absolvents) 1994-1998 at Relevant UniversityInstitutes in the Agro-Food Sector 141

Table 6: Austrian Agricultural Structure 1997 142Table 7: Number of Agricultural Holdings in Austria 1951-1997 142Table 8: Agricultural Structure of EU-Member States 1995 142Table 9: Share of Organic Farming in EU-Member States 1995

and Switzerland 1996 143Table 10: Number of Organic Farms in Austria 1970-1998* 143Table 11: Subsidies for Organic Farming in Austria 143Table 12: Industry Statistic for the Food Processing Industry and Trade in Austria* 144Table 13: Development of the Food Processing Industry 1980-1995* 144Table 14: The 20 Largest Food Processing Companies in Europe 1996 144Table 15: The 20 Largest Food Processing Companies in Austria 1998/99 145Table 16: Share of Food Retailing Chain on the Total Turnover of the

Food Retailing Industry in Austria 146Table 17: Share of Food Retailing Chain on the Total Number of Food Stores

in Austria 146Table 18: Main Characteristics of Biotech Firms in the Agro-Food Sector 147Table 19: Deliberate Releases of GMOs in the EU 1992-2000 149

List of Diagrams

Diagram 1: Public Funding of Biotechnology in Austria 1994-1998 (Share ofPublic Funding Organizations on Total Biotechnology Funds in %) 24

Diagram 2: Selected Actors in the Austrian Biotechnology Policy 26Diagram 3: Private Equity Investment as % of GDP in 1998 46Diagram 4: Comparison of Private Equity Raised by Type of Investor in 1998

(Austria/Europe) 46Diagram 5: Pharmaceutical Production in MECU, Purchase Power Parity (PPP)

(1992-1994) 49Diagram 6: Pharmaceutical Production in EBIS Partner Countries per Capita ECU,

PPP (1994) 50Diagram 7: Pharmaceutical Industry Employees (Thousands of Persons) (1994) 50Diagram 8: Pharmaceutical Industry (Manufacturing) Imports and Exports

MECU PPP (1994) 51Diagram 9: Pharmaceutical Industry (Manufacturing) Imports and Exports

ECU PPP per Capita in Austria 1985-1994 51Diagram 10: Pharmaceutical Industry Employees: Share on Total Employment (1994) 52Diagram 11: Total Domestic Market for Pharmaceuticals per Capita ECU PPP (1996) 61Diagram 12: Pharmaceuticals Licensed in Austria (July 1997) 62Diagram 13: Expenses of Health Insurance Companies for Pharmaceuticals

1990-1996 63Diagram 14: Share of Bio-Pharmaceuticals on Total Turnover of Pharmaceutical

Firms (Wholesale Prices) 64Diagram 15: Number of Donors in Selected European Countries per Million Population

(1998) 68Diagram 16: Responses to the Question of Usefulness of Xenotransplantation

in Selected European Countries 72Diagram 17: Responses to the Question of Risk of Xenotransplantation in Selected

European Countries 72Diagram 18: Responses to the Question on Moral Acceptability of Xenotransplantation

in Selected European Countries 73Diagram 19: Responses to the Question on Encouragement of Xenotransplantation

in Selected European Countries 73Diagram 20: Public Sector Research Institutes Conducting Biotechnology Research

in the Agro-Food Sector 86

EBIS – Case Study Austria 1

1 Background to the Case Studies

1.1 General Introduction to Characteristics of the Country

Austria is a small country by geographical size (83 858 km2) and population (ca. 8.1 Million).Its total Gross Domestic Product (GDP) ranks sixth in comparison with other EBIScountries1, however Austria ranks second with its GDP per capita2.

The most important sector of Austrian economy by size is the service sector with about 68%in 1998 (trade 11.8%, accommodation and catering trade 3.7%, traffic and communications7%, banking and insurance 6.6%, real estate, business services, 14.1%, other services12.9%, public services 6.3%).

The second most important economic sector by size is the secondary sector with nearly 30%in 1998 (production of goods 18.9%, construction 7.9%, energy and water supply 2.4%,minery 0.34%). The Austrian drug industry is comparatively small measured by its share oftotal employment (0.25%). Austria is a net-importer of pharmaceuticals, the export/importratio being 0.77 in 1994 and 0.59 in 1998 compared to an OECD average of 1.13 (OECD2000).

The primary sector, i.e., Austrian agriculture, plays only a minor role in the Austrian economymeasured by its contribution to GDP (2.18%). 32.6% of Austria's floorspace is used forfarming. Austrian farming is predominately small structured: nearly 80% of all farms arebelow an acreage of 20 hectare and only 1.3% of all farms exceed an acreage of 100hectare. Furthermore 35% of all Austrian farms are located in disadvantaged mountainousregions (Statistik Österreich 2000).

In 1998 1.63% of the GDP were spent on R&D in Austria (= Gross domestic expenditures onR&D, GERD).3 This figure is below the OECD average of 2.21%. The GERD per capita was$ 387.4 PPP, which is – in spite of recent initiatives to close this gap – still well below theOECD average of $ 470.1. Patent activities of Austrian researchers and inventors are alsobelow the OECD average: The inventiveness coefficient, which measures the number ofpatent applications by Austrian residents is relatively low with 2.3 (OECD 5.3). Thedependency ratio, which measures the relation between non-resident applications andresident applications is rather high and amounts to 45.07 (OECD 3.16) while the auto-sufficiency ratio, which indicates the share of resident applications on national patentapplications is relatively low with 0.02 (OECD 0.24) (cf. OECD 2000).

1 D 1 921 764, F 1 297 401, UK 1 252 776, SP 520 196, NL 349 675, A 188 453, GR 108 580, IRL75 850 (in Million ECU in 1998; EUROSTAT 2000)

2 NL 22 754, A 22 432, D 21 797, IRL 21 668,UK 20 613, F 19 956, SP 16 289, GR 13 330 (in ECUPPP in 1998, EUROSTAT 2000)

3 In January 1999, the Austrian Federal Government set itself the goal to reach a ratio of GERD to GDPof 2.5% until 2005 (Österreichischer Technologiebericht 1999: 8). This goal has now been reiteratedin the agreeement of the two parties forming the new Federal Government (February 2000) andcomplemented by a target of 2.0% by 2002.

2 Baier/Griessler/Martinsen


Austria is a democratic federal republic governed on the national level by a two chambersystem, i.e. National Council (Nationalrat) and the Federal Council (Bundesrat). The NationalCouncil with its 183 members is elected by popular vote on the basis of proportionalrepresentation. The Federal Council has 63 members elected by the legislatures of thecountry's nine federal states (Bundesländer). This body is restricted to reviewing and, insome cases, delaying legislation passed by the National Council. After World War II Austriangovernments were dominated by coalitions of the Social Democrats and the conservativePeople's Party, with power alternating between the two at different times. A particular featureof the Austrian postwar political system was a strong notion of domestic consensus betweenconservatives and social democrats which was expressed in the so called social partnership.The social partnership is a particular pattern of mediation of interests and involves theinterest organisations from both sides of labour as well as government and publicadministration. As a pattern of policy-making the social partnership aims at co-operation ofinterest groups and co-ordination of interest (cf. Talos 1997: 432 ff.). After years ofweakening influence of the social partnership, the formation of the centre/right-winggovernment comprising of the People's Party and the Freedom Party, the social partnershipis in a severe crisis and it can be assumed that it will loose even more of its influence.

The official competence for Austrian technology policy on a federal level is not clear-cut.Since technology policy cross cuts science and industry policy, competencies for technologypolicy are not concentrated in one Ministry, but rather involve a number of ministries.Although each Ministry is responsible for technology policy within its own range of tasks, it isstill possible to discern a few main ministerial actors of Austrian technology policy. These are:the Federal Ministry for Science and Traffic (BMWV), the Federal Ministry for EconomicAffairs (BMwA) and the Federal Chancellory (BKA). After the formation of the new centre/right-wing government in February 2000, responsibilities for science and technology policyshifted (Forschungs- und Technologieförderungsgesetz, FTFG, BGBl. I Nr. 48/2000).

1.1.1 Public Acceptance of Biotechnology

Several systematic surveys were conducted in the European Union with regard to the publicopinion on bio- and gene technology – in 1991 (Eurobarometer 35.1), 1993 (Eurobarometer39.1), and 1996 (Eurobarometer 46.1). The first Austrian analysis of the public awareness ofbio- and gene technology took place in October 19914. Only part of the study has beenpublished, and the items can't be compared with those of the Eurobarometer surveys. Withinthe context of a study on the "regulation of social sustainability" for gene technologicalproducts in the Austrian Gene Technology Act in 1994 (Gentechnikgesetz – GTG) anadditional analysis was carried out that researched the acceptance of various uses of bio-/gene technology in Austria5 (cf. Torgersen/Seifert 1995; Seifert/Torgersen 1996). For a better

4 The analysis was carried out by the Gallup Institute on behalf of the advertising agency Hargitay andList. At that time the advertising agency was doing public relations work for the Immuno Company (cf.Seifert/Torgersen 1996: 49)

5 In October/November 1994, the Institute for Market and Social Analyses – IMAS conducted arepresentative survey on behalf of the Institute of Technology Assessment – ITA at the AustrianAcademy of Sciences ("Institut für Technikfolgenabschätzung der Österreichischen Akademie der


comparison with EU data the standardized questionnaire of the Eurobarometer 39.1 in 1993was used6. The next turn of questioning within the context of the Eurobarometer 46.1 in 1996was also carried out in Austria – which was at this point already a member state of theEuropean Union (cf. Appendix 1 and Appendix 2 in Durant et al. 1998).

Table 2: Comparison between Europe and Austria in Selected Risk-Domains

Correlated indicators Europe Austria

Acceptance and riskconsciousness

reverse proportional:in those countries where the riskpotential is thought to be high, thelevel of acceptance decreases, andthe other way round.

proportional:very little acceptance goes hand inhand with a low level of riskconsciousness.

Demand for controlby the governmentand acceptance

reverse proportional:in countries with a low level ofacceptance the demand for control bythe government is high, and the otherway round.

proportional:a low demand for control by thegovernment goes hand-in-hand with alow level of acceptance.

Risk assessment andthe demand forcontrol

proportional:in countries with a high level of riskconsciousness the demand for controlby the government is also high, andthe other way round.

proportional:a low level of risk consciousness goeshand-in-hand with a low demand forcontrol.

Specialist knowledgeand acceptance

reverse proportional:in countries with a high level ofknowledge the level of acceptance ofbio-/gene technology is relatively low,and the other way round.

proportional:a low level of special knowledge goeshand in hand with a low level ofacceptance.

The analysis of the public opinion in Austria on bio-/gene technology, which was carried outin 1994, showed that Austria plays a "special role" compared to other European countries (cf.Seifert/Torgersen 1996, for more details cf. Table 1, Appendix 1): (1) The level of acceptancewith regard to the use of bio-/gene technology in Austria is below average. (2) Austria is alsocharacterized by a low level of risk consciousness. (3) There is hardly a demand for controlby the government in Austria. (4) Besides that, the Austrian population shows a very lowlevel of knowledge about bio-/gene technology. The special part that Austria plays, however,

Wissenschaften"), which included a total of 1135 face-to-face interviews with people of 16 years andolder. Half of the questionnaires contained phrases using the term "biotechnology", whereas the otherhalf used the term "gene technology" (cf. Seifert/Torgeresen 1995: 32).

6 Since the Eurobarometer survey 39.1 took place in October 1993 and the IMAS survey inOctober/November 1994, the "time-lag" problem needs to be taken into consideration in thecomparative analysis: The author of this analysis makes the following statement (cf. Seifert/Torgersen1995: 39): The comparison of the Eurobarometer surveys of 1991 and 1993 showed that there areseveral clearly international trends in the evaluation of different technologies, and of biotechnology inparticular. In 1991 this technology got a more positive rating in several countries than it did in 1993. Inview of this temporal trend a comparison of Austrian data from 1994 with data from theEurobarometer survey in 1993 should be interpreted with caution. The trends may continue and thusblur the relations that were found.


doesn't just result from the fact that the values of the mentioned points are relatively lowcompared to other European countries. More so, Austria's special role is expressed by therather untypical combination of these characteristics – as compared to other countries inEurope (cf. Seifert/Torgersen 1996, 50)

Austria's "special role" also becomes clear in the analysis of the so-called "net global index“7,which enables a division of the countries into two groups according to their patterns ofopinion (cf. Seifert/Torgersen 1996: 50-51):

Table 3: Two Main Clusters of Countries with Respect to Biotechnological RiskPerception and Acceptance

"Concerned“ "Unconcerned"

Countries with a high risk assessment, highdemand for control, and a comparably low level ofacceptance. This includes: Germany, Norway,Denmark, and the Netherlands.

Countries with a low risk assessment, low demandfor control, and a comparably high level ofacceptance. This includes: Belgium, France, theUnited Kingdom, Italy, and Spain.

None of the above groups:

Ireland and Greece: high level of acceptance and high risk assessment

Austria: low level of acceptance and low risk assessment and low demand for control

Since the patterns of opinion among the Austrian population don't match the general opiniontrends of the EU countries, Seifert/Torgersen (1996) assume that the reasons for the lowlevel of acceptance in Austria may be different from those in other EU countries. Onepossible reason may be the relatively strong "general technological scepticism" in Austria: Asto the general evaluation of the technical progress in various technological fields, the positiveexpectations in Austria in all the aforesaid technological fields are rather low compared toother European countries. The optimistic expectations are especially low with regard to bio-/gene technology. Knowing about the "general technological conservativism" and the"technological scepticism" among the Austrian population respectively, the low level ofacceptance in combination with low risk assessment, demand for control, and knowledgeshould be interpreted as an "intuitive" rather than a "conscious" rejection (cf. Seifert/Torger-sen 1996: 53). The "general technological scepticism" goes hand-in-hand with distrust or acertain "unease" in connection with the topic of bio-/gene technology, which goes without anycritical explanation or specialist knowledge. At that point Seifert/Torgersen (1996: 54) hadalready come to the conclusion that in certain cases this latent scepticism or unease oflaymen may unexpectedly turn into open resistance and lead to escalations, as it was thecase in Zwentendorf and Hainburg (cf. Chapter 1.1.3). This prognosis was confirmed in thepublic debates on the topic of gene technology during the following years – which reached its

7 Calculation of the "net global index“ for each country: the deviation of the variables "generalacceptance", "general risk assessment", and "general demand for control" from the EU average (cf.Seifert/Torgersen 1996: 50).


height in the Gene Technology – Popular Initiative in 1997 (cf. below in this Chapter andChapter 3.3.4).

As to the acceptance and risk assessment, several differentiations are made in all theEuropean countries based on the different usage of bio-/gene technology in all the Europeancountries (cf. Seifert/Torgersen 1996: 52): The acceptance of bio-/gene technologicalprocesses is clearly positive in medicine or micro-organisms with any ecological benefits.However, the acceptance of the use of bio-/gene technology in livestock and foodstuffs isnegative throughout Europe – actual rejection. Austria matches the European trend withregard to the differentiation of acceptance or rejection according to the different ranges ofapplication, but the level of acceptance lies below EU average in all areas.

The Eurobarometer survey 46.1 in 1996 once again confirms Austria's "special role" withinthe European Union (cf. Wagner et al. 1998, for more details cf. Table 2, Appendix 1). Justlike in 1994, the Austrian population takes on an extremely critical and sceptical positiontowards bio-/gene technology compared to other European countries: An above-averagenumber of Austrians don't believe that the use of bio-/gene technology is "useful" and"acceptable" (negative values). The positive expectations in biotechnology in Austria arelower than in any other EU member state, and further development should not beencouraged (negative values). Nevertheless the risk assessment is comparably low. Thisextremely negative evaluation of bio-/gene technology is combined with a comparably highlevel of contact with the topic (having "heard something about“ or "talked about“ modernbiotechnology). One would expect that the high level of exposure to the topic goes hand inhand with a high level of special knowledge. But this is not the case in Austria: The opinionpattern in Austria is unique because of the fact that in spite of the high level of contact withthe topic the level of specialist knowledge among the population is comparably low, bio-/gene technology carries an extremely "menacing" image hat, and its level of acceptance iscomparably low (cf. Wagner et al. 1998). As in 1994, Austria shows a high level of "generaltechnological scepticism" compared to other countries in the EU: there is a rather smallamount of positive expectations in technological developments, technological innovationsare met with scepticism and pessimism rather than optimism.

One reason for the high level of contact with the issue in Austria is the medial presence ofthe topic of bio-/gene technology within the context of the public debates on the first releaseapplications for GMOs in Austria and of the discussions about a ban on the import of GMmaize and GM soya starting at the beginning of 1996 (cf. Chapter 3.3.4). Especially thetabloid newspapers brought the topic of bio-/gene technology to the public with headings like"Keep Austria Gene Free“, so that the majority of the population has at least "heardsomething about“ the topic. The fact that these news reports did not attach great importanceto information or explanations but rather focused on negative publicity for bio-/genetechnology may explain that despite the fact that the Austrian population is familiar with thetopic, the level of specialist knowledge is still extremely low (cf. Wagner et al. 1998: 19).

Medical applications of bio-/gene technology were met with more approval in Austria – aswell as in other European countries – than its application in the area of agriculture and food


processing. The authors offer two possible explanations for the different levels of acceptanceof different bio-/gene technological applications: On the one hand, the aforesaid medicalapplications in the Eurobarometer survey 1996 don't intend to cross any species barriersbetween and within the plant and animal kingdom. On the other hand, people are much morepersonally affected by medical applications. The personal benefit from medicaldevelopments can be easily understood by everybody. Compared to that, the connectionbetween the application of bio-/gene technology in agriculture or foodstuffs and a directpersonal benefit is less obvious and thus makes these applications seem rather unnecessary(cf. Wagner et al. 1998: 21).

During the course of the heated public debates in 1996 and 1997 on the first releaseapplications for GMOs and the ban on the import of GM maize and soya on an EU level (cf.3.3.4) the latent scepticism and the "unease" of the Austrian population with regard to theuse of gene technology in agriculture and food production turned into a concrete political"manifestation of their annoyance": In 1997 the public controversy reached its height with theso called "Gene Technology – Popular Initiative". The popular initiative is a form of directdemocracy that represents the right of the Austrian population to take initiatives – legalproposals or bills – with no obligations for the Federal Parliament (for more details cf.Appendix 2). The popular initiative was directed at genetic engineering in connection withfood production, the release of transgenic organisms, and taking out patents for livingbeings. The popular initiative showed an extremely high level of participation and was thesecond most successful popular initiative in Austrian history: It was signed by 1 225 790Austrians – which corresponds to 21.23 % of the people eligible to vote at that time (cf.Chapter 3.3.4).

Table 4: Results of the Popular Initiative on Gene Technology in Austria

period of voting number of valid votes% of people entitled to

votesupported by

April 7-14, 1997 1 225 790 21.238 members of

Parliament (GreenParty)

Source: Federal Electoral Authority (Österreichische Bundeswahlbehörde): Results of Popular Initiatives

An analysis of the voters' dynamics (cf. Hofinger/Ogris 1998) showed that the fact thatpeople signed the Popular Initiative on Gene Technology can't be explained by traditionalpatterns of conflict (left/right), but that the support of this popular initiative goes right acrossthe entire population. Hofinger/Ogris (1998: 86) describe the driving forces for this high levelof participation in the Popular Initiative on Gene Technology as a mixture of eco-protest,technological scepticism, and tabloid-actionism, which has had a surprisingly broad effect inAustria. Wagner et al. (1998) believe that the rejection of bio-/gene technological applicationsin agriculture and food production has two different reasons. The people who signed thePopular Initiative on Gene Technology may thus be divided into two extremely differentgroups (cf. Wagner et al. 1998: 20): The first group is said to have progressive politicalviews, which would imply a sort of "green" environmental form of resistance to new


technologies. These people also signed the second popular initiative – the "Popular Initiativeon Women's Rights", which was conducted at the same time as the Popular Initiative onGene Technology, and they supported the Green Party or the Liberal Party (LiberalesForum). The second group is said to have a rather conservative political approach implying asort of "blue" or "black" conservative form of resistance to new technologies. These peopleonly signed the Popular Initiative on Gene Technology but not the "Popular Initiative onWomen's Rights", and they supported mostly conservative parties such as the People’sParty (ÖVP) or the Freedom Party (FPÖ). The supporters of the Social Democratic Party(SPÖ) could be found in both groups.

The influence of the media and the tabloid press in particular on the population's opinionabout gene technology is frequently discussed in connection with the emotional campaign forthe Popular Initiative on Gene Technology and the heated debates on the first releaseapplications for GMOs (cf. Chapter 3.3.4). Although the Popular Initiative was promoted bythe tabloid press, the politico-scientific analyses reject the thesis of a one-dimensional effectof the media on people's opinions (cf. Wagner et al. 1998, Grabner 1999): On the contrary,they proceed from a complex interrelationship between news reports and public opinion: themedia take up already existing opinions and views and portray them in a sensational andexaggerated way, which in turn reflects on the population8. The fact that gene technologywas already strongly disapproved of in Austria before it appeared as a central topic invarious news reports confirms this thesis of a complex interrelationship between theportrayal by the media and the public opinion (see above this Chapter: IMAS survey 1994 incomparison with the Eurobarometer 1993).

1.1.2 Specific Characteristics of Austria Which May Affect Development ofBiotechnology

(1) An important characteristic which may affect the development of biotechnology is theAustrian party system: Since 1945, there were four parties represented in the government(cf. Müller 1997: 230). Both SPÖ (the Social Democratic Party) and ÖVP (the conservativePeople’s Party) were represented more than once and in a long-term period. On the onehand, it can be stated that the important actors are a constant factor of the government. Onthe other hand, fundamental changes have appeared. Firstly, between 1966 and 1987, it is a"normal" option of governmental constitution to exclude one of the two parties mentionedabove. Secondly, since 1970 the role of the most important governmental party was passedover from the ÖVP to the SPÖ – until 2000, when the ÖVP became the most important partyagain. Thirdly, the circle of parties taken into consideration for a coalition has widened.

After overcoming its initial "ghetto-position", the FPÖ (the Freedom Party) has the status of apotential coalition partner since the 1970s. Since 1986, when a change in leadership tookplace, the SPÖ, the Green Party and the Liberal Forum consider the FPÖ on principle as notsuitable for a coalition. Concerning the assessment of the FPÖ as a potential coalition

8 For a more general discussion of the relationship between the categories "fear", "genetic engineering"and "democracy" from a political science perspective see Martinsen (2000).


partner, there are three groups within the ÖVP (cf. Müller 1997): (1) those who on principlesupport a coalition between the ÖVP and the FPÖ, (2) those who on principle exclude thispossibility and (3) political pragmatics, who, because of tactical considerations and in orderto improve their own position in the negotiations for a coalition, refuse to exclude any of theoptions. Since its entry into the parliament, the Green Party has developed towardsbecoming suitable for a coalition. The Liberal Forum has presented itself as suitable for acoalition since its foundation. In the 1990s, three realistic options emerged: the LargeCoalition (SPÖ-ÖVP), the Small Coalition (ÖVP-FPÖ) and the "Ampel"-Coalition ("trafficlight"-coalition of SPÖ-LF-Green Party) (cf. Müller 1997). After the parliamentary elections in1999, the FPÖ superseded the ÖVP as second most important party. The coalition betweenÖVP and FPÖ is prevailing since February 2000.

The Green Party entered the Parliament in 1986. This was a novelty in Austrian policy (cf.Dachs 1997), since the Green Party does not belong to any of the three traditionalideological positions in Austria – the christian-social-conservative, the socialistic or social-democratic and the nationalistic position (cf. Horner 1997). The presence of an eco-alternative party in the Parliament is a climax in the development of new social movementssince the beginning of the 1970s – especially for the ecological movement - whichquestioned the actual political monopoly of the established actors and institutions andopposed the measures of the political-administrative system. Since 1986, the Green Party ispermanently established in the Austrian party system. Even though considered a small partyrelated to the votes, it plays an important role as "controller", "theme innovator" and indiscovering and formulating problems. During the last years though, the Green Party haschanged from a "party of protest" to a "party of change" (cf. Dachs 1997: 314).

(2) The social movements in Austria are surely of special importance for the development ofbiotechnology (cf. Gottweis 1997): Since the 1970s, there is a varied scene of socialmovements in Austria as well as in the other western countries: the civic action group, theecological movement, the new women’s movement, the alternative movement, the youthprotest movement and the new peace movement. Even though the social movements inAustria were brought into action at a relatively late time compared to other countries, theywere able to at least achieve some success in a few matter of detail. The new socialmovements in Austria developed considerable power especially in preventing great projectsof the energy and road construction sector. Historically seen, the most important success ofthe ecological movement was to prevent the putting into operation of the already completednuclear power plant in Zwentendorf, against the will of both the government and the socialpartners. In November 1978, due to massive public pressure, the government carried out areferendum on the Federal Act on the Peaceful Use of Nuclear Energy in Austria (opening ofthe nuclear power plant Zwentendorf). 50.5% of the Austrians who voted said "no" to thepeaceful use of nuclear power (3 183 486 voters, that is 62.62% of the people eligible tovote) (for more details cf. Appendix 2). The second climax for the ecological movement wasthe conflict about the planned Danube power plant Hainburg - a project supported both bythe government, the electricity sector of economy and the social partners. After theoccupation of the Hainburger-Au by activists and because of the great mobilization in thepublic, the government was finally forced to give up the project. These historical


achievements of the ecological movement led to the development of a potential of protestwhich can still be mobilized (cf. Gottweis 1997).

(3) Another Austrian characteristic worth mentioning is the so-called "social partnership", acorporatist mode of decision-making, where monopoly-like federations are included in theformulation and performance of policy (cf. Tàlos 1997): The social partnership is borne bythe umbrella organizations of the employers' associations and the employees' associationsas well as the government or the competent ministries. The pattern of decision-making ischaracterised mainly by co-operation and co-ordination of the social partners. Theirdecisions are reflected in the macro-level of policy, mainly in the sectors of income,economy, social and labour market policy. Changes in the political constellation of power onthe governmental level have not yet lead to the questioning of the social partnership. Sincethe end of the 1970s though, the influence of the parties on the process of formulation ofpolitical demands and of political decision-making has grown. Especially concerning thesectors of energy and environmental policy, the social partners have not always achievedsuccess. As it is shown by the conflicts about Zwentendorf and Hainburg, the social partnerswere not able to have their way with their conceptions of energy policy – extension of nuclearpower and water power – against the will of the population and against the strategies oflegitimation developed by the parties (cf. Müller 1997; Talos 1997).

(4) One central problem in Austria has been the fragmentation of competencies and duties intechnology policy (Martinsen/Melchior 1994: 106-134). For this reason the Federal Govern-ment has tried to initiate a purposeful, integrated strategy. One step to foster an activeresearch and technology policy has recently been made by dissolving three advisory boards,which had overlapping responsibilities: the council for science and research ("Rat fürWissenschaft und Forschung"), the promotion research council ("Forschungsförderungsrat”),and the council for technology development ("Rat für Technologieentwicklung"). It wasargued that the outcomes of the dissolved councils "unfortunately had been very little" (DUZ2000: 24). A new central council has now been established to create new impulses forshaping a homogenous and effective strategy: the council for research and technologicaldevelopment ("Rat für Forschung und Technologieentwicklung") (Bundesgesetzblatt 2000).The eight members of the council, who were nominated by the Federal Ministry of Traffic,Innovation and Technology (BMVIT) and the Federal Ministry of Education, Science andCulture (BMBWK), are representatives of universities and economics from Austria andabroad (cf. Cordis). The most important renewal is that the council is authorised to launchinitiatives in the public on its own. The council has been provided with a fund of ca. 5 Mill.ATS (1.5 Mill. ATS of this amount will be for external expertise and evaluation studies), butthe government obtains the sovereignty over the budget. At the moment it is not possible togive a valid statement as to how strong the new instrument will influence the development ofAustrian (bio-)technology. The future will show, if it is really a "substantial reform intechnology policy" (Steiner 2000, in: Der Standard, May 20th, 2000).

Résumé: The political culture in Austria is particularly influenced by "Social Partnership" andis embedded in a tradition of seeking to evade conflicts. The described comprehensive


system of co-operation is above all relevant for technology policy (cf. Aichholzer et al.: 378-399):

(1) The "cartel of associations" implies a partial competition to the independent democraticformation of objectives at the parliamentary level and is limiting the scope of action on bothsides.

(2) On the one hand the corporate policy mode enhances the chances of findingcompromises and of reaching positive effects regarding social integration. On the other handpossible dysfunctional effects are repeatedly mentioned as drawbacks which are visible inthe form of trends towards immobility and an impairment of the innovative potential.9

(3) Another aspect concerns the goal and implementation of technology policy in a moredirect way: The social partners' common basis of interest mainly consists of a growth andproductivity coalition. As the corporate style tends to neglect competing demands (e.g. ofsocial movements), the agreement mechanism might reach limits when new challengesoccur, especially regarding certain socially and ecologically delicate questions of technologypolicy.

It is interesting to note that the signs of crisis of social partnership became apparent at thesame time that Austria entered the European Community. The European integration processas well as the amazingly dynamic international development of technology imposed asignificant pressure on a small state like Austria, which is highly exposed on the worldmarket. One of the most important arguments to enter the EU was a "negative" one: the fearof a raising technological gap between Austria and the other industrialised Europeancountries (cf. Martinsen 1994: 471)10. In a recently published book about "Austrian policy"the authors (cf. Pelinka/Rosenberger 2000) argue that this illuminates a general politicalpattern in Austria where the political progress has always been forced "from outside" – or ina "top-down-mode" (as a consensus of elite circles). However, the latter option, whichcorrelates with a culture of "forced harmony", has been increasingly eroding during the lastyears - this process is called De-Austrification ("Entaustrifizierung"). Are there still specialAustrian features in the policy area? Focussing on the latest political developments in Austriait could be argued that the remarkable size of a right populist party, which has become partof the government, is an unintentional consequence of the social Partnership. In this sense itcould be regarded as a "new" special Austrian characteristic of the political institutionalsystem (cf. Pelinka/Rosenberger 2000: 248).

9 In our context it might be of some interest that this opinion is underlined in some sense by theoutcomes of the report "Benchmarking the Competitiveness of Biotechnology in Europe", carried outby the Science and Policy Research Unit (SPRU) at the University of Sussex: assessing thecompetitiveness in biotechnology, Austria ranked last among 15 European countries (cf. Profil 1997:94-96; with a similar tenor see Autischer 1998: 4-5).

10 For an adoption of this thesis to the question of biotechnology development see Martinsen (1999: 65).


1.2 General Government Policy for Biotechnology

1.2.1 Overview of the General Government Policy for Biotechnology since 1980

Politico-scientific analyses talk about four temporal phases of the Austrian policy onbiotechnology (cf. Wagner et al. 1998: 17). (1) pre-history from Asilomar11 up to 1985, (2)"dawn" of 1985-1990, (3) opening and closure of the debate in 1991-1994, and (4) escalationas a consequence of the first release applications in 1995-1997. The detailed description ofthese four – and by the end of 1999 already five – phases predominantly falls back upon thepolitico-scientific analyses by Grabner 1999, Grabner/Torgersen 1998, Wagner et al. 1998,Gottweis 1997 and Martinsen 1997, who have extensively researched the process of theAustrian policy on biotechnology.

Phase 1: Pre-history from Asilomar up to 1985: The topic of biotechnology still hardlyreceives any attention from the political side. In the Eighties the western industrial countriesstarted to develop specific biotechnology programs. Compared to other countries, theAustrian policy on biotechnology was much more reserved. However, it was still taken to bebasically necessary and important. The main question was whether Austria would be able tocatch up on the research backlog that existed compared to other countries. The nationalpolicy on biotechnology followed the "principle of modernization for catching up on anybacklogs" and was aimed at making up for any research lags, making sure that theopportunities of biotechnology wouldn't be missed, and that Austria wouldn't be overrun bythe dynamics of international technological developments. The research areas ofbiotechnology and gene technology were added to the key programme of the nationalgovernment's "Austrian Research Conception 1980" ("Österreichische Forschungskonzep-tion 1980“). The Federal Ministry of Science (at that time Federal Ministry of Science andResearch, Bundesministerium für Wissenschaft und Forschung – BMWF) asked a projectteam to take stock of the Austrian potential in the area of biotechnology and to draw upresearch concepts for this sector. Their main goal was to develop a strategy forbiotechnological research. After that, the research priority of "biotechnology and genetechnology" was set up in 1984 with the intention to encourage the transfer of knowledgefrom research institutions to the industry. The recommended strategy was to continue tofurther the main research areas of Austrian biotechnological and gene technologicalresearch – however, there was no exploration of technological niches and specializationstrategies in the context of international competition.

Phase 2: "Dawn" of 1985-1990: The first initiatives to support biotechnological research anddevelopment as well as the first discussions about the regulation of bio- and gene-technology take place in Austria. The research priority of "biotechnology and gene-technology" starts in 1985 and ends in 1990. Its initial phase focused on improving theexisting infrastructure in university or non-university research institutes. The following phaseof actual product support was aimed at improving the cooperation of science and industrial

11 Scientific Conference of Microbiologists on the topic: The Future of Gene technology. February 24-27,1975 in Asilomar. Taking stock of the past debate. Discussion about possible political-regulatorystrategies for dealing with the risks of gene technology.


practice and at encouraging basic research with a long-term benefit for political economy.The responsibility for these support programs was shared by two ministries: The BMWF tookcare of organization and coordination, and the BMÖWV at that time (Federal Ministry forPublic Economy and Traffic – Bundesministerium für öffentliche Wirtschaft und Verkehr) wasresponsible for the programme to promote applied research. In 1988 this programme wasreplaced by the Innovation and Technology Fund (Innovations- und Technologiefonds – ITF).Between 1985 and 1987 the BMWF established another project group, which should onceagain draw up an "overall biotechnological concept" – but, just like in 1984, no coherentpriorities resulted from that. Biotechnology and gene technology were also supported by theAustrian Science Fund (Fonds zur Förderung der wissenschaftlichen Forschung – FWF) andthe Austrian Industrial Research Promotion Fund (Forschungsförderungsfonds für diegewerbliche Wirtschaft – FFF). For the support of basic research the FWF set up theresearch priority of "gene technology" in 1984. The FFF does not have a specific researchpriority, but the field of biotechnology is separately dealt with since 1985. During the secondhalf of the 1980s, the Institute for Molecular Pathology (Institut für Molekulare Pathologie –IMP) was established in Vienna – a private institute for cancer research, which was foundedin 1986 as a joint venture of the Boehringer Ingelheim Company and GenentechIncorporated. This was accomplished with the help of large sum of promotional money fromthe Federal Government and the Province of Vienna. From the beginning, this institute wasmeant to be part of a planned Center of Excellence in bio-medial research (symbiosis ofuniversity education and research and industrial research and development). On the initiativeof the BMWF two scientific societies for the support of biotechnology were founded in themid-1980s: The Austrian Society for Genetics and Gene Technology (ÖsterreichischeGesellschaft für Genetik und Gentechnik – ÖGGGT) and the Austrian Society forBiotechnology (Österreichische Gesellschaft für Biotechnologie – ÖGBT) (Source: face-to-face interview – chairman of the ÖGGGT). The mid-1980s also give rise to the discussionsabout a legal regulation of gene technology in Austria. At the beginning of this debate genetechnology is discussed in connection with the various aspects of reproductive medicine.Several symposiums and discussion circles were held by different Federal Ministries (e.g. forEnvironment, for Health, for Science, and the Undersecretary of State for Women Affairs)and public organisations like the Chamber of Labour (Kammer für Arbeiter und Angestellte –AK). The discourse was limited to a small circle. Especially the fields of science and industryshowed a rather small interest in a legal regulation. The opponents of gene technologyraised the question whether the use and research of gene technology was legitimate andmeaningful, and they demanded the strictest possible regulation. At that time, genetechnology was primarily criticized by the "Gen-ethic Network Austria" ("Gen-ethischesNetzwerk Österreich") – an offshoot of the German GEN – whose work was mainly based onexpert knowledge from Germany. Environmental organizations were not yet involved all thatmuch, except for the "Forum of Austrian Scientists for Environmental Protection" ("Forumösterreichischer Wissenschaftler für Umweltschutz"), which published a catalogue ofdemands for a law on gene technology in 1990.

Phase 3: Opening and closure of the debate in 1991-1994: The support programs of theBMWF and BMÖWV expired in the 1990s. However, the support of biotechnologicalresearch and development by the two funds – FWF and FFF – continued. In 1993 the ÖGBT


is asked to set up new priorities in the field of biotechnology. Since the programme wassimilar to the prior programs, its extensive structure made it equally impossible to define anyclear priorities. Along with the application for EU membership in 1989, Austria started toadjust its national legal system to the EU directives. In view of the EU directives for genetechnology that had existed since the beginning of the 1990s, the legal regulation of genetechnology was inevitable. In 1991, the Ministry for Health started negotiations for a law ongene technology, whereby it tried to incorporate all the relevant groups – including relevantNGOs. The first draft of the Gene Technology Act was submitted for discussion in the springof 1991 by the Ministry of Health and the question whether regulations were actuallynecessary was discussed once again. Since the discussion was still limited to a smallamount of people the Parliament decided to convoke a Parliamentary Inquiry Commissionwith the title "Technology Assessment of Genetic Engineering" (parlamentarische Enquete-Kommission "Technikfolgenabschätzung am Beispiel Gentechnologie"). The InquiryCommission was meant to start up an extensive public discourse on the opportunities, risks,and effects of gene technology, and to define standards for the sensible and responsible useof gene technology. In spite of the differences of opinion, they successfully managed to writea consensual final report. At the same time, the ministerial draft of the legal text was drawnup and the Ministry of Health announced that they would incorporate the recommendationsof the Inquiry Commission into the draft. The final version of the Austrian Gene TechnologyAct was submitted in the autumn of 1993. However, several important issues that the InquiryCommission had worked on were neglected in this legal draft. In 1994 the Gene TechnologyAct (GTG) was passed in the Federal Parliament with only the votes of the parties in power(for more details of the GTG cf. Chapter 1.4.1). The prior discussion in the Parliament wasnot taken into consideration. The recommendations of the Inquiry Commission were largelyignored and the hopes that the Parliament would have more influence on the legislation weredashed. The second goal of the Parliamentary Inquiry Commission – promoting a broaderpublic discussion – was not met either. Neither the Parliamentary Inquiry Commission in1992 nor the passing of the Gene Technology Act in 1994 – two crucial political events –were noticed by the public.

Phase 4: Escalation as a consequence of the first release applications in 1995-1997: Thefirst release applications for GMOs gave rise to a sudden public interest in the topic of genetechnology in agriculture and foodstuffs (for more details cf. Chapter 3.3.4). The primarilyemotional debates escalated and led to the Popular Initiative on Gene Technology in 1997(cf. Chapter 1.1.2).

Phase 5: Rigidity of the policy on gene technology in the agricultural and food sector –extensive support policy in the bio-medical and bio-pharmaceutical sector in 1998-1999:After the Popular Initiative on Gene Technology the Federal Government is faced with adifficult situation: it is caught between EU regulations and the public pressure in its owncountry. Honouring the success of the popular initiative, several points of the GeneTechnology Act were changed in 1998 (for more details cf. Chapter 1.4.1). As to the use ofgene technology in agriculture and food production, one may well say that the policy onbiotechnology found itself in a rigid state. Compared to that, the areas of bio-medical andbio-pharmaceutical research and development benefit from an extensive support policy and


new political initiatives. Among other things, the Impulse Programme Biotechnology wasinitiated in 1999 (for more details cf. Chapter 1.2.2 and 1.2.3).

1.2.2 Policies for Public Sector Research and Technology Transfer

In general no Austrian public funding organization had a special biotechnology programmebetween 1994 and 1998. Biotechnology was funded exclusively within the regularinstruments of the respective funding organization, which in general supported individualprojects by response mode. The activities of the relevant funding authorities will bediscussed in chapter 1.3.1.

Between 1994 and 1998 several initiatives existed in various organizations to promotetechnology transfer between public sector and research. These programs will be discussedtogether with two more recent initiatives starting in 1999 in chapter 1.2.3.

1.2.3 Industrial Policy

At present (July 2000) several programmes exist to encourage firms to adopt biotechnology,namely:

- Tecma (Technology Marketing Austria) founded in 1998 by the BMwA- "Impulse Project Post Docs for Industry", carried out by the FWF since 1998 on behalf

of the BMWV- Relay Programme and the Young Researcher Programme of the FFF- Impulse Programme Biotechnology (IPB), carried out since May 1999 by the Innovation

Agency (Innovationsagentur) on behalf of the BMWV and the BMwA- Competence Centers (Kompetenzzentren), a BMWV instrument, which targets pre-

competitive research in a number of technologies and since January 2000 also includesa Biotechnology Competence Center.

All these initiatives are relatively recent and will be discussed in the following in more detail.

Tecma (Technology Marketing Austria)

Tecma is an Austrian agency to exploit patents. It commercializes research results fromAustrian universities, firms and private individuals by licensing and selling patents and know-how. Tecma should enable researchers and inventors to make gains from their inventions.Tecma provides the following services: assessment of patentability and market potential ofinventions; active search for exploitation partners; bridge financing of domestic and foreignpatent application; negotiation of license agreements; monitoring of license fees;arrangement of research co-operations; patenting loans; individual information andcounseling as well as public presentations (Innovationsagentur 12/99).


Impulse Project Post Docs for Industry

Since 1998 the FWF on behalf of the BMWV carries out the "Impulse Project Post Docs forIndustry". The objective of the programme is to facilitate know-how transfer from university toindustry. So far 28 Impulse Projects have been funded, four of them relevant for biotech-nology. Funding per project is limited to ca. EURO 80 000 (letter from BMWV, April 10th,2000).

Relay Program

This development programme of the FWF is carried out in cooperation with the FWF. In thisprogramme companies are involved in research as observers right from the basic researchstage. The projects are taken over by the firms as they approach the marketing stage(htttp://inovacion.ita.es/inforJISS/FFF_in.htm).

Young Researchers Program

The aim of this programme is to involve young researchers in joint projects with companiesand thus to increase cooperation between industry and public research (htttp://inovacion.ita.es/inforJISS/FFF_in.htm).

Impulse Programme Biotechnology (IPB)

Since May 1999 the Innovation Agency (Innovationsagentur) by order of the BMwA and theBMWV handles the Impulse Programme Biotechnology (Impulsprogramm Biotechnologie, inthe following IPB). The IPB acts as an information center and address to turn to for youngbiotechnologists and physicians who want to exploit their ideas and research results (BMwA/BMWV et al. 1999: 2). The IPB has the following objectives:

1. To promote the establishment of new biotech firms and thus to improve the structure of

the biotechnology sectors.

2. To advise biotechnology researchers about patenting and exploiting their research

results.

3. To open up financing instruments (especially venture capital) by linking and

strengthening existing funds.

4. To strengthen innovative capabilities by promoting the co-operation between science and

industry.

5. To support biotechnology start-ups by providing infrastructure and space.

6. To support the exploitation and commercialisation of patents which are not exploited by

means of setting up new firms.

7. To create an innovation friendly environment for biotechnology companies.


8. To contribute to increased scientifically sound public information about modern

biotechnology and thus to contribute in the long run to increased public acceptance

(letter from BMwA, March 16th, 2000).

In order to reach its goals, the IPB provides the following services: Advice in patenting,licensing, establishing of a new firm as well as financing; bridge-financing of patenting costs;support in contacting financiers and funding organizations; support in contacting publicauthorities (e.g. permissions); information about and arrangement of available lab space inexisting research institutes; activities at Austrian universities to raise researchers’ awarenessfor company formation; business management training at Austrian universities forbiotechnology students (Unterer 1999: 40-41).

The duration of the IPB is limited to four years. In 1999 the IPB was endowed with ca. EURO1.45 Million (Austrian Press Agency 1999). For the following years an endowment of EURO3.6 Million is planned. However, since it is intended to combine new money with existingprivate and public funds, it is possible to provide an amount many times greater than thisfigure. So far, six projects have been selected, with a total volume of investment ofapproximately EURO 14.5 Million to 21.8 Million (personal communication with IPB,November 18th, 1999).

Competence Centers

Competence Centers ("Kompetenzzentren") are a generic instrument to spur pre-competitiveresearch as well as private and public sector research co-operation. At its beginning, aCompetence Center involves a core group of 3 to 7 key researchers and 10 to 20 otherscientific personnel. After a three year initial phase, the personnel should include 5 to 15scientific key researchers and 20 to 40 other scientific personnel. Public funding ofCompetence Centers is limited to 60% by federal, provincial and municipal authorities aswell as interest organizations. 40% of the money has to come from the industry. The durationof a Competence Center is limited to seven years, however a 7 years extension is possible.After four years, a Competence Center will be evaluated. On January 12th, 2000 the Ministerof Science and Traffic took the decision to fund the "Competence Center for BiomolecularTherapeutics" (BMT). The BMT will be funded by the BMWV for four years with ca. EURO4.3 Millions (total project volume ca. EURO 12.4 Millions, Press release of the FederalMinister for Science and Traffic, January 12th, 2000).

These programmes particularly aim to foster the research industry network. This is a reactionto a structural problem which also can be found on a European level: the EuropeanCommission identified a so-called "European Paradox" in the technological field - a slogan todescribe the gap between the efforts in basic research and R&D investments and the abilityof firms to turn into market shapes and profits (cf. Grande forthcoming).


1.2.4 Intellectual Property Rights (IPR) Policy and Similarity/Difference to EC-Policy

Intellectual Property Right Protection concerning biotechnology has been a controversialpolicy field in Austria. In 1984 the Austrian Parliament made the Patent Act consistent withthe European Patent Convention (EPC), in particular by adopting the EPC definition ofpatentable inventions. In 1997 however, anticipating industry-friendly regulations, aheterogenous coalition of environmentalists, churches and concerned citizens launched ananti-biotechnology-petition, which besides a referendum demanded: "No Patents on Life".Given its tremendous success (the petition was signed by 1.27 million Austrians) thegovernment came under heavy public pressure to proceed with a more restrict biotechnologypolicy. However, the initiators' expectations that the petition would lead to an (even) morerestrictive Austrian biotechnology policy were disappointed. Only one year after thereferendum, the Austrian delegation at the Council voted in favour of the European PatentDirective (98/44 EC), which harmonised European Intellectual Property Rights. Thus,Austrian IPR in biotechnology must not differ from European regulations.

1.2.5 Policy to Promote Public Acceptance of Biotechnology

The heated public debates and the Popular Initiative on Gene Technology called for newmeasures to improve the population's knowledge about the research and application of bio-and gene technology in order to raise the level of acceptance for gene technologicalapplications. The organization of an exhibition called "gentechnik pro & contra“ ("genetechnology – the pros and cons") presents one of these measures (cf. Ausstellunggentechnik pro & contra). This exhibition is intended to extensively inform the public aboutthe topic of bio- and gene technology and increase the population's knowledge by discussingboth the opportunities and the risks of new technologies. The exhibition "gentechnik pro &contra" ("gene technology: the pros and cons") is a touring exhibition that started out inVienna in 1998. Since then it has already been presented in five other Austrian cities.

Table 5: The Exhibition "gentechnik pro&contra" across Austrian Cities

Locations Period of event Locations Period of event

Vienna April 30 - June 30, 1998 Linz Oct 20 - Oct 31, 1999

Graz Sep 26 - Oct 26, 1998 St. Pölten March 9 - April 4, 2000

Salzburg March 24 - May 30, 1999 Judenburg May 12 - Oct 29, 2000

Source: Ausstellung: gentechnik pro & contra

The exhibition was organized by the "Plattform Gentechnik & Wir" ("Platform GeneTechnology & We) – a combination of various scientific societies12 (cf. Plattform Gentechnik

12 Österreichische Gesellschaft für Genetik und Gentechnik (Austrian Society for Genetics and Genetechnology), Gesellschaft Österreichischer Chemiker (Society of Austrian Chemists), ÖsterreichischeAkademie der Wissenschaften (Austrian Academy of Sciences), Österreichische Gesellschaft fürBiotechnologie (Austrian Society for Biotechnology), Verein Österreichischer Lebensmittel- undBiotechnologen (Association of Austrian Food- and Biotechnologists), Österreichische Gesellschaft


& Wir). This platform serves as a source of information at the interface between science andthe public. The defined goal of this exhibition is to eliminate the fears and misinformationamongst the population and make room for a constructive dialogue (cf. Ausstellung:gentechnik pro & contra). That's why experts from the Federal Environment Agency, theInstitute for the Assessment of Technological Effects at the Austrian Academy of Sciences,the Chamber of Labour, the Inter-universitary Research Center for Labour, Society, andCulture, and representatives of the Catholic Church were incorporated as well. Theopponents of gene technology (representatives of NGOs and the initiators of the PopularInitiative on Gene Technology) were also invited to take a stand in this event. The exhibitionwas supported by a number of Federal Ministries – BMWV, BKA/BMFV, BMUJF, BMwA,BMLF, and BMAGS – as well as the government or other organizations of the respectiveProvince. In 1997 and 1998 the BMWV provided about EURO 21 800 (ATS 300 000) for thisexhibition (Source: written information from BMBWK13, April 20th, 2000).

The measures to raise the people's level of knowledge and acceptance with regard toresearch and development also include the establishment of coordination and informationbureaus: The "Bureau for the Coordination of Public Relations of the ÖGGGT"("Koordinationsstelle Öffentlichkeitsarbeit der ÖGGGT") is promoted by the BMWV (sinceApril 2000 by the BMBWK) (Source: written information from BMBWK, April 20th, 2000). The"INFOGen – Information Bureau for Gene Technology" ("INFOGen – Informationsstelle fürGentechnologie") at the Interuniversitary Research Center for Technology, Labour, andCulture is supported by the government of the Province of Styria and the public healthdepartment of Graz. "Gene Technology Information" ("GentechnikInformation") providesextensive information on the topic of gene technology on the Internet (cf. Gentechnikinfor-mation) and is looked after by the Ministry responsible for the general affairs of genetechnology at a given time (until April 2000 BKA/BMFV; since April 2000 BMSG14).

The first report of the Gene Technology Commission (cf. BKA/BMFV 1999: 25-26) also dealswith the insufficient specialist knowledge about gene technology among the Austrian people.It discusses the increasing need to supply basic knowledge about gene technologicalapplications. Due to the great opportunities of gene-analyses and gene-therapy for medicineand gene technology for food production this field will play an increasingly important role inpeople's lives. The long-term goal is to inform patients and consumers who have sufficientspecial knowledge about gene technology and the possible unhealthy, ecological and socio-economical effects to make conscious and critical decisions and choices. The comparativeanalyses in the EU member states (cf. Eurobarometer surveys Chapter 1.1.2) show thatAustria needs to catch up on the supply of specialist knowledge. The Gene Technology

für Ernährung (Austrian Society for Nutrition), Österreichische Biochemische Gesellschaft (AustrianBiochemical Society), Österreichische Gesellschaft für Humangenetik (Austrian Society for HumanGenetics).

13 Due to the change of government in Austria the affairs of science and research are located in theFederal Ministry for Education, Science and Culture – Bundesministerium für Bildung, Wissenschaftund Kultur – BMBWK since April 2000.

14 Since April 2000 the Federal Ministry for Social Security and Generations – Bundesministerium fürsoziale Sicherheit und Generationen – BMSG is the relevant authority for general affairs of bio- andgene technology.


Commission clearly recommends the establishment of a wide range of educationalinstitutions and points out that it is necessary to lead an open and objective discourse inspite of the different views. In this connection, the exhibition "gentechnik pro & contra" ("genetechnology: the pros and cons") and the resulting discussions are favorably mentioned.

1.2.6 Policy to Encourage Interaction Between the Various Networks

The instruments, which have been established recently to spur industry-public sectorresearch cooperation have been described in chapter 1.2.3 already. Political measures toencourage the interaction between the knowledge network and the public in order to promotethe general knowledge of the population about biotechnology are discussed in Chapter 1.2.5.

1.3 The Science Base

In order to identify research institutes active in biotechnology a questionnaire was sent out to102 institutes at universities, university hospitals and non-university research organisations.The addresses were derived from lists from relevant publications (Rosian et al. 1998,Clement et al. 1998, BIT 1999 as well as personal communication). After several remindersby telephone 78 institutes answered the questionnaire, i.e. a respondent rate of ca. 77%.

35 responding research institutes stated that they were active in biotechnology (i.e. 44.8%)and 43 institutes declared they were not (i.e. 55.1%). Most institutes active in biotechnologyare university institutes (31); only four research organizations are non-university researchorganizations (cf. Table 6). Most institutes are located in Vienna (17), followed by Innsbruck(8), Graz (6), Niederösterreich (3) and Salzburg (1).

Almost all responding research institutes are active in fundamental research (32), themajority of them being active in bio-pharmaceutical research (22, cf. Table 7). Approximatelyone quarter of the institutes are active in the agro-food sector and only one research institutein the equipment and supply sector. Nine institutes indicated that they were active inbiomedicine and 7 institutes confirmed their activity in environmental research.

The 32 institutes which confirmed the number of their research staff employed 2 063researchers (full-time equivalent). From the three sectors studied in this project, the sectorwith the most scientific staff is by far the bio-pharmaceutical sector with 557 researchers,followed by the agro-food sector (121) and the equipment and supply sector (24).Furthermore 86 researchers are employed at responding Austrian research institutes in theenvironment sector and 1 080 in sectors other than these four sectors (cf. Table 8).


Table 6: Number of Institutes by Organisations

Organisation Number of Institutes

University of Vienna 11

University of Innsbruck 8

University of Graz 4

University of Agriculture (Vienna) 2

University of Technology Graz 2

University of Technology of Vienna 1

University of Veterinary Medicine (Vienna) 1

Danube-University Krems 1

University Salzburg 1

Non-University Research Organizations 4

Total 35

Source: IHS-Survey 1999/2000

Table 7: Number of Institutes by Research Areas (multiple entry was possible)

Research areas Number of Institutes

Fundamental Research 32

Biopharma 22

Agro-Food 9

Equipment 1

Biomedicine 9

Environment 4


Table 8: Research Areas by Personnel

Personnel Number of responding Institutes

Biopharmaceuticals 557 18

Agro-food 121 8

Equipment 24 1

Environment 86 3

Others 1 080 11



In summary, Austrian public biotechnology research activities are institutionally concentratedat universities. The majority of these institutes are located in Vienna, but there are alsoresearch institutes in Innsbruck, Graz and Salzburg. The most important sector from thethree sectors studied (measured by numbers of institutes and researchers) is by far thebiopharmaceutical sector, followed by the agro-food and the equipment and supply sector.

1.3.1 Amount of Funds Available for Biotechnology Research 1994-1998and Main Funders

In order to identify the amount of public biotechnology funds, a survey was conducted amongthe main Austrian funding bodies. The survey involved the following institutions: BKA,BMAGS, BMwA, BMWV, BMUJF (including UBA), Anniversary Fund of the Austrian NationalBank (ÖNB), European Recovery Programme-Fonds (ERP), FWF, FFF, ITF, InnovationAgency, IPB, BMLF, Governments of the Federal States of Burgenland, Kärnten,Niederösterreich, Oberösterreich, Salzburg, Steiermark, Tirol, Vorarlberg and Vienna. Not allinstitutions could provide data or could break their data down to the three sectors. In case ofmissing data, we refered to data from Reiss 1999.

Diagram 1 and Table 9 present the main public organizations of Austrian biotechnologyfunding by their share on total biotechnology funding between 1994 and 1998. They showthe relative importance of the two research organizations FFF and FWF in biotechnologyfunding. The two funds provided almost three quarters of all direct public biotechnologyresearch funds between 1994 and 1998. The most important organization according to theamount of direct funding is the Industrial Research Promotion Fund (FFF) with 59% of allpublic funds, followed by the Austrian Science Fund (FWF) with 13.7%. Third is the City ofVienna with 9.3%, which renewed its biotechnology policy in 1997. Fourth with 5.1%, is theAustrian National Bank (ÖNB), which promotes medical research. Fifth, is the federal stateNiederösterreich (NÖ), which provides 5.1% of total biotechnology funding.15 In contrast tothe dominant role of FWF and FFF direct contract research from Ministries plays only aminor role (7.3% of all public funds). The following Ministries were substantially involved inbiotechnology funding: BMWV (2.7%), the Federal Ministry for Agriculture and Forestry(BMLF, 2.2%), the BKA (1.3%) and the BMwA (1.1%). However direct contract research doesnot tell the whole story about the relative importance of a particular ministry for researchfunding. Because of their financial support of the FWF16 and the FFF17 respectively theBMwA and BMWV are key actors in the public research funding of biotechnology. Tenth byamount of direct funding is the Innovation agency (1%), followed by a number of otherfunding bodies (1.6%) such as several federal states, the Umweltbundesamt (UBA) and theMinistry for Environment, Youth and Family (BMUJF).

15 However, these figure must be interpreted with great caution because it is based on the assumptionthat ca. 5% of the subsidies for economy of the federal state of Niederösterreich is relevant forbiotechnology (letter from Wirtschaftsförderungs- und Strukturverbesserungsfonds NÖ, February 15th,2000). It is sound to assume that the amount of 5% might be overestimated.

16 The BMWV contributed 90% of the total budget of 60 MECU to the FWF in 1997. The remaining 10%came from the Austrian National Bank (Reiss 1999: AU-11).

17 The Federal Government contributed 52 MECU of the total budget of the FFF in 1997 (total budget136 MECU, Reiss 1999: AU-12).


Diagram 1: Public Funding of Biotechnology in Austria 1994-1998 (Share of PublicFunding Organizations on Total Biotechnology Funds in %)

59

13,7 9,3 5,1 3,1 2,7 2,2 1,3 1,1 1 1,60

25

50

75

100

FFF FWF Vienna ÖNB NÖ BMWV BMLF BKA BMWA IA Others

Source: IHS-Survey 1999/2000; Reiss 1999

Of the three sectors under study, the one with the most public funding is the bio-pharmaceutical sector with a share of 68.9% of all funds; followed by the agro-food sector(3.3%). No public funding for the equipment sector was reported in our survey, however it issound to assume that the amount of funding not specified by the three sectors (25.8%) alsoincludes some funding for this sector. 2% of public biotechnology funding was aimed at othersectors, over and above the three sectors named (e.g. risk and safety research, textile).

The following section deals with those public actors which are involved in biotechnologyfunding. Diagram 2 depicts the relevant Austrian public actors active in biotechnologyfunding as they were organized by 1999/2000. The most important actors for biotechnologyfunding on ministerial level are the main technology policy actors, i.e. the Ministry forScience and Transport (BMWV) and the Ministry for Economic Affairs (BMwA). Besidesthese two, there are several other ministries with competences and interests inbiotechnology policy, i.e. the Federal Ministry for Agriculture and Forestry (BMLF), theMinistry for Environmental, Youth and Family Affairs (BMUJF), the Federal Chancellery(BKA) and Ministry for Labour, Social Affairs and Health (BMAGS)18.

18 The BKA and the BMAGS are grouped in table 2 under the heading "other Ministries".


In order to understand public biotechnology funding patterns in Austria one has to distinguishbetween two groups of organizations: Firstly, there are a number of Ministries which arefunding R&D projects in biotechnology because of their particular responsibilities. Secondly,there are research promotion funds which finance fundamental research and industrial R&D.The BMWV and the BMwA are main financiers of these funds via lump-sum funding. Thefollowing section describes the responsibilities of Ministries and research funds and theirrelative importance for public funding of biotechnology.

Research Promotion Funds

Austrian Industrial Research Promotion Fund (FFF)

The Austrian Industrial Research Promotion Fund (FFF) finances research and developmentprojects and innovation projects carried out by industry. Furthermore, it supports scientistswho together with companies work on new products. The fund offers the following services:evaluation of projects, cooperation with know-how transfer agencies, assistance in thesearch for joint ventures. The fund was established in 1967 and is an independent legalentity. Currently the FFF provides a variety of programs (htttp://inovacion.ita.es/inforJISS/FFF_in.htm). It did not establish a specific biotechnology program, but provided fundingwithin its regular instruments.

From 1994 to 1998 the FFF funded 116 projects totaling to about EURO 44 Mio (cf. Table10). Estimated 90% of its funding were dedicated to the biopharmaceutical sector (personalcommunication FFF, November, 11th 1999, July 18th 2000).

Table 10: FFF Biotechnology Funding 1994-1998

Year Number of Projects Funding in EURO Share of total FFF funding in %

1994 25 8 602 937 6.4%

1995 23 7 161 254 7.0%

1996 16 7 648 743 6.4%

1997 25 11 791 167 8.6%

1998 27 8 816 814 6.9%

Total 116 44 020 915

Source: personal communication with FFF, November 11th,1999; July 18th, 2000

Austrian Science Research Fund (FWF)

The FWF, established in 1967 as an independent body, supports fundamental research withthe following instruments: (1) Individual Projects, (2) Selective Actions, (3) Special ResearchPrograms, (4) Science College, (5) Promotion of Young Scientists. Projects are selected forgranting only after an international peer review procedure.


Individual projects are submitted by individual researchers and are funded for a maximumduration of two years. The average costs of individual projects are ca. EURO 56 700 (FWFletter April 10th 2000).

Selective actions are limited to a maximum duration of 5 years (evaluation after 2 years).They are submitted by groups of researchers and are aimed at the promotion of researchpriorities. As a rule, selective actions are aiming at the establishment of national,interdisciplinary networks, based on division of labour, which work on medium term andlarger research projects (average costs ca EURO 392 400, letter from FWF, April 10th.,2000).

Special Research Programs (SPR) run for up to 10 years (mid term evaluation after 3 and 6years) and are aiming at the creation of centers of excellence according to internationalstandards (average costs ca. EURO 784 900, letter from FWF, April 10th, 2000).

Science Colleges are potentially unlimited in time (evaluation after three years) and arededicated to the education of top scientific trainees. Science Colleges are set up in specificareas, where Austrian science has particular performance (average costs ca. EURO290 700, letter from FWF, April 10th, 2000).

Basically, the FWF follows the "bottom-up-principle", i.e. the FWF does not give any thematicguidelines for its funding activities (response mode) – budgets are not earmarked. Thereforethe FWF does not have any specific special programs for particular research areas orresearch issues.

The FWF did not break down its funding by the three sectors bio-pharmaceuticals, agro-foodas well as equipment and supplies, since it is hard to foresee the definite area of applicationof the fundamental research it funds (letter from FWF, March 4th, 2000).

Innovation Agency

The Innovation Agency (for further information on this topic see Austria Innovativ 1999)provides risk capital and is owned by the Republic of Austria (51%), the BürgesFörderungsbank Ges. m.b.H. (20%), the Austrian Chamber of Commerce (20%) and othersocial partners (9%). The Innovation Agency did not have any special biotechnologyprogramme from 1994 to 1998. However, in 1998 and within one of its regular instruments –the "seed financing programme" – it supported one bio-pharma project with EURO 726 728.Apart from this, the innovation agency did not fund any project within the agro-food and theequipment and supply sector (email from Innovationsagentur, February 16th, 2000).


Ministries

Federal Chancellory (BKA)

Within the Federal Chancellory (BKA) the Federal Ministry for Women's Affairs andConsumer Protection (BMFK) (in co-operation with the BMWV) was responsible for theimplementation of the Austrian Gene Technology Law until spring 2000. The BMFK hadamong other things the following responsibilities: It granted permission to release GMOs orto work with GMOs in closed systems in all cases which neither fall within the authority of theBMWV nor the animal testing or pesticide law respectively (GTG § BGBl. Teil 1 Nr. 21/1997).It kept the "gene technology register" which records all products that contain or consist ofGMOs (GTG § 101 c, cf. Clement et al. 1998: 206) and was also responsible for authorizinglaboratories to carry out predictive gene-analysis on humans for medical purposes (GTG §68 Abs. 1). The GTG also requires research in the area of bio-safety. Therefore the BKA andthe BMWV support research projects which are dealing mainly with safety issues ofbiotechnology.

Between 1994 and 1998, the BKA spent a total of EURO 970 618 for research in the areasof safety research in biotechnology, gene-analysis and risk assessment for deliberatereleases of GMO and GMO food etc. The BKA did not support any research in the sectorsbio-pharmaceuticals, agro-food and equipment and supply, since these sectors are beyondthe responsibilities of this authority (letter from BKA February 8th, 2000).

Federal Ministry for Labour, Health and Social Affairs (BMAGS)

The BMAGS is responsible for general health policy and occupational safety and health. TheBMAGS did not have any biotechnology funding activities between 1994 and 1998, and theMinistry does not plan any future funding activities in this area (letter from BMAGS, February25th, 2000).

Federal Ministry of Economic Affairs (BMwA)

The BMwA has the task to promote industry policy as well as to stimulate the biotechnologyindustry and the creation of new companies. The BMwA is an important actor inbiotechnology policy for two reasons: On the one hand, the BMwA is one of the main actorsin innovation and technology policy. In this context the ministry is one of the main financiersof the FFF and the Innovation Agency (which provides risk-capital). Via its links to funds likethe FFF, the Innovation Agency and the Innovation and Technology Fund (ITF), the ministryis also involved in supporting industrial biotechnology-research. On the other hand, theBMwA also directly finances individual R&D projects in the area of biotechnology.

The BMwA did not have a special programme for biotechnology between 1994 and 1998,however within the framework of its economic-technical contract research it spent funds onbiotechnology. This contract research should "gain knowledge, which is relevant for thenature of the tasks of government" (FAX from BMwA, March 16th, 2000). The BMwA


supported 12 projects with a total of EURO 796 385. Eight of these projects were dedicatedto the agro-food sector, the remaining three to other biotechnology research. None of theprojects were within the bio-pharma or the equipment and supplies sector.

In 1998 the BMwA, together with the BMWV, made preparations for the Impulse-Program-biotechnology (Impulsprogramm Biotechnologie), which was launched in 1999. The Impuls-Programme is executed by the Innovation Agency (for a detailed description of thisprogramme cf. chapter 1.2.3).

Federal Ministry of Science and Transport (BMWV)

The BMWV is active in biotechnology policy for two reasons. Firstly, it is responsible foruniversities, publicly financed research and science policy. Within these responsibilities theBMWV supports the FWF, universities, university hospitals, the Austrian Academy of Scienceand some non-university research organisations. Secondly, the BMWV has competenciesaccording to the Austrian Gene Technology Law (Gentechnik-Gesetz, GTG). It grantspermission to universities and federal research institutions under its authority to releaseGMOs or to work with GMOs in closed systems (GTG § 100 Z 1). The BMWV also contractsresearch in biotechnology.

Between 1994 and 1998, the BMWV supported research in biotechnology with a total ofEURO 2 020 405 (Reiss 1999: AU-10). This money was not spent within the framework of aspecial biotechnology program, but by a number of different instruments. Firstly, the ministryused its contract research to support biotechnology research. Secondly, the BMWVsupported EU-co-operations by funding the (a) initiation costs of EU-projects, (b)improvement of the infrastructure necessary for these co-operations and (c) additionalfunding for EU-Projects. Thirdly, the BMWV funded interdisciplinary risk and safety researchaccording to § 102 of the Austrian Gene Technology Law. Finally, the Ministry supportedactivities to promote public acceptance of modern biotechnology (exhibitions, establishmentof the Co-ordination Office Public Relations Biotechnology/Koordinationsstelle Öffentlich-keitsarbeit Gentechnik, letter from BMWV, April 20th, 2000).

In future, the BMWV plans to install a special programme "gene research". The goal of thisspecial programme is to support fundamental research, technology development andtechnology transfer as well.

Federal Ministry of Environmental, Youth and Family Affairs (BMUJF)

The BMUJF provides subsidies to improve environmental performance of the industry. In thiscontext the ministry also finances biotechnology projects. Moreover, the ministry supportsactivities of the Federal Environment Agency (UBA). The BMUJF had no special fundingarea in biotechnology between 1994 and 1998. It supported only one project from 1994 to1997, this being dedicated to enzymes in detergents. Furthermore it supported technologyassessment with emphasis on biotechnology application (email from BMUJF, March 24th,2000).


Between 1994 and 1994, the Federal Environment Agency (UBA) did not have any specialbiotechnology program. It contracted 6 research projects totalling to EURO 318 179. In awider sense these projects can be classified as belonging to the agro-food sector (safetyresearch, risk-assessment and monitoring of GMO, letter from BMUJF, March 24th, 2000).

Federal Ministry of Agriculture and Forestry (BMLF)

The BMLF finances research projects in the fields of agriculture, forestry and waterresources. From 1994 to 1998 it funded biotechnology projects with ca. EURO 1.6 Millions(Reiss 1999: AU-14).

Charities

Austrian National Bank (ÖNB)

The Anniversary Fund of the Austrian National Bank (Jubiläumsfonds der ÖsterreichischenNationalbank) focuses its funding activities on research in economics and medicine. From1994 to 1998 the ÖNB supported 162 projects with a total of EURO 3 781 822, which wereclearly in the field of biotechnology19 (cf. Table 11). Since the ÖNB concentrates its fundingactivities to medicine and economics, it seems justified to assume that this amount can beattributed to the bio-pharma sector in a wider sense.

Table 11: ÖNB Biotechnology Funding 1994-1998

Year Number of Projects Funding in EURO

1994 27 732 906

1995 33 804 488

1996 31 661 468

1997 32 775 564

1998 39 807 395

Total 162 3 781 821

Source: letter from ÖNB, February 15th, 2000; own calculations

19 The ÖNB made available for the EBIS project the titles and amounts of funding for all the projects itsupported between 1994 and 1998 in the natural sciences and medicine. With the help of an expert itwas possible to identify 162 projects which were clearly relevant for biotechnology. For 31 projectswhich were funded with EURO 669 317, it was not possible to conclude clearly (based alone on thetitle) whether they were relevant for biotechnology. In this context we want to thank Mrs. Lydia Sattlerfor her support during the project.


Federal States

The Federal States of Burgenland (letter from February 24th and personal communicationfrom February 25th and March 3rd, 2000) and Oberösterreich (letter from November 29th,1999) did not fund any biotechnology projects between 1994 and 1998. The Federal Statesof Kärnten, Niederösterreich, Salzburg, Tyrol and Vorarlberg did not have any specialprogramme for biotechnology but did support biotechnology in general with small funds.Vienna is the only Austrian Federal State, which – although only recently – put particularemphasis on supporting biotechnology.

The Federal State of Kärnten does not support fundamental research (personalcommunication with Amt der Kärnter Landesregierung, February 4th, 2000), and has noresearch funding of its own (personal communication with Kärntner Wirtschaftsförderungs-fonds, February 4th, 2000). However, it does provide additional Funding to projects funded bythe FFF, the Innovation and Technology Fund and the European Recovery Programme to amaximum of 20%. The Federal State did not have any special biotechnology program.Between 1994 and 1998 within its regular funding instruments for R&D and technologytransfer, the Kärntner Wirtschaftsförderungsfonds funded 6 enterprises within thebiotechnology sector with EURO 283 424. No special programme is planned for the future(e-mail from Kärntner Wirtschaftsförderungsfonds, February 22nd, 2000).

Also the Federal State Niederösterreich did not have a special biotechnology program.Biotechnology projects have been funded with the regular Wirtschaftsförderung withestimated EURO 2 298 035 (estimated 5% of all subsidies for enterprises, personalcommunication with Amt der Niederösterreichischen Landesregierung, February 23rd, 2000).However, it can be assumed that this amount might be overestimated.

The Federal State Salzburg funded one biotechnology project between 1994 and 1998 withEURO 5 668 (letter from Land Salzburg, February 15th, 2000).

The Federal State Steiermark funded some projects in the agro-food sector, however, withoutproviding the exact amount of funds.

The Federal State of Tyrol had no special biotechnology programme and fundedbiotechnology within the regular subsidies for enterprises. The provincial government fundedseveral projects in the bio-pharmaceutical sector with more than EURO 360 000. However,since these projects were carried out from one and the same company, the exact amount offunding was not available (personal communication with Amt der Tiroler Landesregierung,March 29th, 2000).

Also the Federal State of Vorarlberg has no special biotechnology programme (letter fromAmt der Vorarlberger Landesregierung, February 24th, 2000). The provincial governmentpromoted biotechnology within its regular R&D subsides in total with EURO 120 637 (EURO55 740 biopharmaceuticals, EURO 31 831 agro-food, EURO 33 066 others (textile). At


present, the provincial government has no particular plans for a special biotechnologyprogramme.

After having been involved in the funding of the Vienna Biocenter (VBC) in the 80s, the Cityof Vienna recommenced its biotechnology promotion activity in 1997. The aim of theseactivities is to develop Vienna as one important biotechnology site, which is able to keep upwith other urban biotechnology clusters in Europe. The primary goal of this municipalinitiative is to provide the opportunities for establishing new dedicated biotechnology firmsand thus to tap the entrepreneurial potential available in this city. Focus of funding is bio-pharmaceuticals, on the one hand for reasons of public acceptance and on the other handbecause of the medicine cluster already existing in the city. There is no special municipalbiotechnology program, but the city government uses various established policy instrumentsto further biotechnology. Between 1995 and 1999, the Wiener Wirtschaftsförderungsfond,one of the main communal funding organisations, funded bio-pharmaceutical projects withca. EURO 6.9 Million. Within and beside these activities, the City of Vienna supports theextension of existing facilities on the Vienna Biocenter. Several firms have already beenestablished on the site of the Vienna Biocenter and it is planned to establish more newcompanies. Furthermore the City of Vienna is planning to create a ”Cluster-Management” forbiotechnology. The cluster management will manage the site, will try to enlist newenterprises and will support start ups in the phase of their establishment (advise in patenting,funding etc.). The cluster-management will closely co-operate with other public fundingorganisations (e.g. Impulse Programme Biotechnology) (personal communication with MA26, City of Vienna, November 25th, 1999).

Conclusions: Between 1994 and 1998, no Austrian public funding organisation had a specialprogramme for biotechnology, but biotechnology was funded by several organisations withintheir regular funding instruments. The leading organisations, in terms of funding, were thetwo research funding organisations FFF and FWF. Compared with these two organisationsthe Ministries were less relevant in terms of the direct funding of individual projects. With theexception of the City of Vienna, the Austrian Federal States are only playing a small role inbiotechnology funding. Biotechnology funding was primarily focused on the bio-pharmaceutical sector. Little public money was spent on the agro-food sector and almost nofunds were dedicated to the equipment sector. In recent years, the funding regime started tochange. In 1999 The BMwA together with the BMWV launched a special programme forbiotechnology start-ups (Impulse Programme) and in January 2000 the BMWV started aCompetence Centre Biotechnology, which is dedicated to university/industry co-operation.Moreover, in 1997 the City of Vienna recommenced its biotechnology policy by supportingthe development of a research centre in the city.

1.3.2 Funding Regime for the Science Base and Its Effect on Academic Interest inInteracting with Industry

cf. Chapter 1.2.3 and 1.3.1.


1.3.3 Rules for Academic Intellectual Property and Employment Conditions and theEffect on Commercialisation

In 1979 Austria became an official member of the European Patent Office (EPO). After acompetition among several European Countries concerning the location of a sub-office, theAdministrative Council (legislative body) of the EPO finally chose Vienna to be in charge ofthe EPIDOS, the European Patent Information and Documentation Office. Though thisinstitutional setting would provide an excellent basis for researchers to get information andcopies of patent documents, Austrian Universities and research centres lack otherfundametal prerequisites for transforming their knowledge to a sufficient extent intopatentable inventions. While Intellectual Property Protection is considered to be a vital andindispensable basis for privately owned companies in order to repay their research anddevelopment expenditures, Austrian universities and research centres have not yet fullygrasped the funding opportunities provided by patents and potential incomes from licenceagreements.

According to patent behaviour, the Austrian scientific community in the field of biotechnologycan be differentiated between two groups:

On the one hand, academic researchers are interested in publication rather thancommercialisation of their findings. This kind of behaviour can be attributed to the characterand attitude of researchers towards their work and is supposed to change very slowly. As aresult, know-how and potential incomes from licence agreements get lost irretrievably.

On the other hand, many researchers at universities are quite aware of the advantagesprovided by the protection of their inventions, though they face a number of problems.

1. It is difficult for them to find an experienced lawyer who is able to provide support andconsultancy as to whether, and in what way, an invention is patentable.

2. Researchers wishing to patent their inventions are left alone with the rather complicatedprocedures of a patent application. In particular, young researchers, engaged in patentissues for the first time, would be in need of professional help.

3. Patent application costs are considered very high and therefore act as an additionaldisincentive for those wishing to patent their inventions.

4. Another possible disincentive for researchers to patent their inventions are patentregulations at universities. While the Austrian Patent Law (cf. Schönherr 1987) ensuresthat, whatever an employee may invent during the course of employment will be ownedby him or her (§ 6 PatG), it makes an exception for state employed inventors such asuniversity researchers (§ 7 (2) PatG). In these cases, the responsible federal ormunicipial authority can apply for the patent (Aufgriffsrecht). If the responsible authorityfails to exercise its right (deliberately or unintentionally) within four months the inventionremains with the employee (Kucsko 1995). In practice, however, the federal authorities,in particular the Ministry of Science and Transport, usually reject this right and leaves


researchers their inventions for commercialisation. For that reason inventions made atthe university can be treated like those made by independent researchers.

As a result, many researchers who would under different conditions have patented theirfindings, avoid doing so.

A recent study on patent behaviour within Austrian universities and academic researchcentres lists three patterns of behaviour of patenting researchers (Rosian et al. 1998):

1. Researchers establish their own company, where they can directly commercialise theirinvention.

2. Researchers apply for a patent and offer their invention to a company, which in return(re)finances their research, carries the costs for patenting and/or gives them a share ofthe turnover accured with the patent.

3. Researchers have a long-term contract with the industry. A contract provides thecompany, on the one hand with an exclusive right to exploit potential inventions. On theother hand, it can include the so called "right of first refusal", which means, that theresearcher has to offer his patentable invention to the company first. If the company thenrefuses to execute its right, the researcher is entitled to offer his or her invention toanother company.

Recognising the weak biotechnology patent activities, Austrian government recently starteda number of policy initiatives to spur the commercial exploitation of research results: In 1998the Ministry of Economic Affairs founded Tecma (Technology Marketing Austria), anorganisation which tries to copy the so-called Technology Licencing Offices (TLOs). Tecmahelps researchers to commercialise their inventions. In 1999 the Ministry of Economic Affairsand the Federal Ministry of Science and Transport initiated an "ImpulsprogrammBiotechnologie" which also assists researchers in their patenting activities (Innovations-agentur 1999). Furthermore, the government supports cooperation between researchcentres, universities and private companies (Competence Centers) within the so called"K plus" Programmes20. In 2000 the Minister for Science and Transport approved the fundingof the "Competence Center for Biomolecular Therapeutics" (BMT).

In summary, Austrian academia still prefer to publish rather than to patent their researchresults. However, awareness for the importance of patenting21 is growing within the Austrianbiotechnology research community. Also, the government has started to take a number ofsteps to facitlitate and foster commercialisation of research results.

20 "K plus" Competence Centres are research institutions which are established for a limited period oftime with the goal to intensify the co-operation between science and economy and have the legalform of a company with limited liability (GmbH) (cf. Forschungsbericht 2000: 9).

21 For general information about patents as indicator of technology performance see OECD 1999a: 90.


1.3.4 Post-Graduate Courses Available in Higher Education

In 1998/1999 the Donau-University Krems provided a post-graduate course "applied bio-medicine" (Anwendungsorientierte Biomedizin) (BMWV 1998: 92).

1.3.5 Personnel Involved in Doctoral Training and Number of Awarded PhDsin the Period 1994-1998

The survey carried out by the IHS within the scope of the EBIS led to the result of 35research organisations in total, who were working on the field of modern biotechnology andgene technology. Four of these are inter-universitary or non-universitary institutions where nograduations are possible. However, these institutions often offer scholarships for doctoralstudents who, at the same time, take part in the educational programs of one of theuniversities. Between 1994 and 1998 there were a total of 318 Master degrees (firstuniversity graduates) and 367 PhDs (second-university graduates) for bio- or gene-technological theses obtained at the 31 university research institutes and university hospitalswhich were interviewed (cf. Table 12 and 13). Compared to the other biotech-part sectors,the greatest number of graduations by far are achieved in the biopharmaceutical sector; thiscan be said about both the first-university graduates as well as the second-universitygraduates. Data of the personnel involved in doctoral training are not available.

Table 12: Number of Masters 1994-1998 at Relevant University Institutes in theBiotech Sector

Sector 1994 1995 1996 1997 1998 Total

Biopharma 36 17 39 20 23 135

agrofood 4 4 4 5 4 21

equipment 4 4 4 4 4 20

environment 4 5 4 4 4 21

others 23 17 17 17 17 91

Total # of graduates* 60 58 63 70 67 318

Total # of institutes 13 14 15 16 17

* Since not every research organisation has broken down the number of graduates according to thedifferent biotech-part sectors, the "total" number of graduates is more than the total number of graduatesof the biotech-part sectors.



Table 13: Number of PhDs 1994-1998 at Relevant University Institutesin the Biotech Sector

Sector 1994 1995 1996 1997 1998 Total

biopharma 27 20 22 24 34 127

agrofood 8 8 7 6 11 40

equipment 7 1 2 2 4 16

environment 7 1 2 3 4 17

others 20 24 25 18 23 110

total # of graduates* 81 67 61 66 92 367

total # of institutes 15 18 18 15 18

* Since not every research organisation has broken down the number of graduates according to thedifferent biotech-part sectors, the "total" number of graduates is more than the total number of graduatesof the biotech-part sectors.


1.4 Other Issues

1.4.1 Regulation of Bio-/Gene Technology

The Gene Technology Act (Gentechnikgesetz – GTG) was published as a federal law on July12th, 1994 (BGBl. Nr. 510/1994). It is the implementation according to European law of twoCouncil Directives into Austrian law: The GTG is the realisation of the Council Directive forthe use of genetically modified micro-organisms in contained systems (90/219/EEC) and theEU guidelines for the deliberate release of GMOs into the environment (90/220/EEC) whichalso regulates the placing of GMOs and GMO products on the market. The GTG hasbecome effective on January 1st, 1995. Following the "gene technology popular initiative" inApril 1997 – which was supported by 21.23% of the voters, the GTG was already amendedby the federal law Amendment of the GTG (Gentechnikänderungsgesetz) in 1998.

Compared to the Gene technology Acts in other countries and according to EU legislation,the Austrian GTG is a very extensive regulation which focuses on different uses of genetechnology (cf. Clement/Kolb et al. 1998). Apart from the questions of safety connected tothe work with GMOs in contained systems, releases and placement on the market of GMOs,the GTG also regulates human genetic engineering (gene analyses and gene therapycarried out on human beings).

The GTG is divided into twelve Sections: Section I contains general regulations andobjectives of the GTG: Protection and furthering (§ 1); Scope of law (§ 2): Principles (§ 3):prevention principle (to protect human health and the environment), future principle, step-by-step principle, democratic principle, ethic principle. § 4 contains various definitions of terms.


Table 14: Bio-/Gene Technology Regulation in Austria

Gene technology Act (Gentechnikgesetz – GTG)Realisation of the Council Directive 90/219/EEC and the Council Directive 90/220 EEC

• Gene technology Act – GTG: Bundesgesetz, mit dem Arbeiten mit gentechnisch verändertenOrganismen, das Freisetzen und Inverkehrbringen von gentechnisch veränderten Organismen und dieAnwendung von Genanalysen und Gentherapie am Menschen geregelt werden (Gentechnikgesetz -GTG, BGBl. Nr. 510/1994, ausgegebenen am 12. Juli 1994)

Content of the Gene technology Act - GTG:

o working with GMOs in contained systemso deliberate release of GMOs into the environmento placement on the market of GMOs and GMO products including labelling of products that

consist of or contain GMOso human gene-analysis and gene-therapy

• Amendment of the Gene technology Act – GTG: Bundesgesetz: Änderung des Gentechnikgesetzes- GTG (BGBl. Nr. 73/1998, ausgegebenen am 22. Mai 1998, Teil I)

Main points of the Amendment:

o civil liabilityo multi-party procedure in the case of the release of GMOso nomination procedure fo experts for the scientific committees of the Advisory Board of Gene

Technologyo control and restoration of the environment in case of any destructiono measures in case of an unauthorised release of GMOso register of products containing GMOso safety documentation

Section II deals with the issue of working with GMOs (micro-organisms, plants, or animals) incontained systems: In relation to the risks they present, operations using GMOs areclassified in four different safety levels (§ 5 GTG): These safety levels differentiate betweenno risk, slight risk, medium risk, and high risk for human health and the environment. Thecriteria for assessing the security hazards of operations using GMOs are laid down in § 6GTG and in the "Ordinance on Work with GMOs in Contained Use" (Systemverordnung,BGBl. Nr. 116/1996)). Depending on the kind of organism (micro-organisms, plants, animals,vertebrates), the type, safety level/categorization, as well as on the individual standards, anotification has to be submitted and a written consent has to be received prior to anyoperations using GMOs in contained systems (§ 19 and § 20 GTG). For the majority of thesenotifications and authorisations the competent authority requires an expert opinion by theresponsible scientific committee within the Gene technology Commission, or, in especiallyrisky cases, a public hearing will have to be held prior to making a decision (§ 22 para. 3).The higher the security level/categorization of an operation using GMOs is, the stricter theorganisational and technical safety measures will have to be. Two specific characteristics forthe creation of trans-genetic vertebrates and for operations using such trans-genetic animalsare: If these animals are constructed by crossing the border-line to other species, theseoperations are only permissible for the purpose of bio-medicine and developmental bio-research (§ 9 para. 1 GTG). If it is an animal experiment that requires an animal experimentauthorisation, as referred to in the Law on Animal Experiments (Tierversuchsgesetz – TVG)of 1988, no additional notification of these operations has to be submitted to the competentauthorities. The animal experiment authorisation serves as a substitute for the necessary


notification which would be required by the GTG for operations using trans-genetic animals(§ 27 GTG).

Section III regulates the release of GMOs and the placing on the market of products: Thedeliberate release of GMOs into the environment has to be authorised by the responsibleauthorities if no prior authorisation exists for placement on the market of these GMOs. Therequired content is laid down in the GTG and in the "Ordinance on Deliberate Release ofGMOs into the Environment" (Freisetzungsverordung, BGBl. II Nr. 49/1997). The releaseshould be carried out in accordance with the step-by-step principle (§ 36 GTG): This includesthe differentiation between "small-scale" and "large-scale" trial releases. The difference isthat the unlimited dissemination and multiplication of GMOs beyond the site of release is"lowered" in the first case and "monitored" in the second case. A release is only permissibleif it is carried out in compliance with the legal provisions, if it can be guaranteed that therewon't be any negative effects on human health and the environment, and if an appropriateliability insurance exists.

Since the Gene technology Act was amended 1998, the official procedure to authorise therelease of GMOs is explicitly a multi-party procedure (§ 39a amendment of the GTG).Notifier: communities (in whose territorial jurisdiction the release will be carried out),neighbouring communities (if the release site borders on them), owner of the release site,neighbours, the responsible (Federal) State. The right of co-determination only exists if,during the course of the hearing procedure, the affected parties submit written objections tothe responsible authority related to the hazards to human health and the environment. Thedesignated public authorisation procedure has to include the votes of other EU memberstates and a public hearing which is carried out in accordance with the "Ordinance on PublicHearings" (Anhörungsverordnung, BGBl. Nr. 61/1997, i.d.F. BGBl. Nr. 164/1998). Theauthorities have to get an expert opinion from the scientific committee for releases andplacing on the market of GMOs. Besides security measures, the authorities also define thetime period during which the notifier collects data about long-term effects on human healthand the environment (§ 46 L 2 and § 40 para. 2), and subsequently submits them to theauthority (§ 46 ). Specific accompanying records concerning every individual release must betaken and kept for at least 10 years after the termination of the release.

If no authorisation that is effective throughout the European Union exists for the placementon the market of products containing or consisting of GMOs, the producer or the Austrianimporter needs to obtain a specific official authorisation (§ 54 GTG). The required content ofthe notification is defined in § 55 GTG and supplemented by the "Ordinance on Labelling ofproducts that contain GMOs" (Gentechnik-Kennzeichnungsverordnung, BGBl. II Nr.59/1998). Prior to the official authorisation, the voting procedure within the EU has to bemore intensive than in the case of releases, because every authorisation of the placing onthe market of GMO products will be effective in all EU member states. In case of an objectionby a member-state, the EU will decide in accordance with Article 21 of the Release Directive.The placement on the market of a product may only be granted by the authorities if theconditions and extent of the placement on the market is clearly specified, and further, only ifnegative effects on human health and the environment can be ruled out. After the placing on


the market of products as referred to in § 54 para. 1 has been authorised, they have to beincluded in the Register of products containing GMOs (Gentechnikregister, § 101cAmendment of the GTG) which may be accessed by the public. In addition to that, productscontaining or consisting of GMOs may only be placed on the market if the labelling complieswith the specific requirements defined in the GTG (§ 62 GTG) and in the "Ordinance onLabelling of products that contain GMOs" (Gentechnik-Kennzeichnungsverordnung, BGBl. IINr. 59/1998). For products containing or consisting of parts of GMOs (i.e. productsthemselves not containing or consisting of GMOs), the GTG provides the legal basics for adirective that prescribes these products to be labelled accordingly.

Table 15: European Authorization Procedures with Regard to the Placement on theMarket of GMOs

Placement on the market of GMOs: Whenever GMOs should be placed on the market they are subject tothe regulations for the placement on the market of GMOs according to the Release Directive

(90/220/EEC):Authorization procedure:

- EU-wide authorization procedure- applies to all member states- Authorization for placement on the

market- implies planting

- Publication of the authorizations:in the official gazette of the EU andin the Register of products containing GMOs of theBKA/BMFV Section IV

The regulations for the placement on the market of GMOs according to the Release Directive(90/220/EEC) don't apply to products that are subject to similar authorization procedures, e.g. food,drugs/medicine.

Placement on the market of GMOs as a food product: Whenever GMOs should be placed on the marketas foodstuffs their notification and authorization is subject to the Novel Food Regulation (97/258/EC):

Notification procedure:- for new foodstuffs that are basically similar

to existing food or food ingredients;- renowned scientific expert opinions or

statements of a responsible authority in themember states;

Authorization procedure:- for new foodstuffs that are not basically similar to

traditional food or food ingredients- prior safety test- decision about authorization prior to placing on the

market- member states: right to raise an objection

Placement on the market of GMOs as drugs/medicine: Whenever GMOs should be placed on the marketas medicinal products in the area of human or veterinary medicine their authorization is subject to theDrug Directive (Arzneimittelrichtline) (87/21/EEC) and the Directive on the Authorization and Control ofMedicinal Products (Verordnung für Genehmigungen und Überwachung von Arzneimitteln)(2309/93/EEC).

Source: Culinar/Nohel et.al 1998: 36-39; Loibl/Stelzer 1997: 33.

§ 63 GTG, which regulates the so-called "Social Unsustainability" (soziale Unverträglichkeit)of GM products, is unique in Austria. It also offers the legal possibility for the FederalGovernment to prohibit the commercial placement on the market of socially unsustainableproducts containing or consisting of GMOs: According to the GTG, social unsustainabilityexists if the basic facts lead to the assumption that such products may cause stress tosociety or social groups which can't be compensated for, and when this burden for society is


not tolerable for economic, social, or ethical reasons. § 63 GTG is implemented in addition tothe provision in § 54 GTG, which generally ties the placement on the market of GMOproducts to an official authorisation and which only takes technical aspects intoconsideration. In § 63 extra-technical, i.e. socio-economic acceptance criteria arestandardised. In his legal opinion Waldhäusl (1995: 24) points out that the “socialunsustainability” clause represents a novelty within the established Austrian law, sinceproduct-related regulations have only been limited to the standardisation of technicalacceptance criteria up to this point. The social unsustainability clause, however, is not veryprecise. In a politico-scientific analysis, Martinsen (1997) comes to the conclusion that theimplementation of this clause is rather problematic. It is quite difficult to determine socialunsustainability, and several terms are in great need of interpretation. In his legal opinion,Waldhäusl concludes that § 63 GTG even violates the legality principle of Article 18 of theAustrian Federal Constitution (Bundes-Verfassungsgesetz B-VG). Additional concerns existwith regard to the basic constitutional rights (liberty of acquisition, inviolability of personalproperty, equality principle) (cf. Waldhäusl 1995).

Section IV regulates the applications of biotechnology in human medicine: Human geneanalysis and gene therapy: Prohibition of manipulations of human genetic material, carryingout and using genetic analyses (confidentiality of data, etc.) Human gene analysis: The GTGonly includes the initiation and carrying out of gene analyses for medical, scientific, andeducational purposes as well as and the use of the results of such gene analyses. Accordingto the GTG, gene analyses are exclusively genetic examinations of human chromosomes,genes, and sections of DNA on a molecular level in order to identify mutations (§ 4 L 23GTG). The GTG categorises gene analyses for medical purposes according to their degreesof predictiveness: (1) analyses to identify a predisposition for a certain disease, (2) analysesto diagnose a manifest disease or a possible future disease connected to that. Geneanalyses for medical purposes may only be carried out if it is ordered by a physician and ifthe examined person is sufficiently informed about the nature, the consequences, and thevalidity of the gene analysis by the physician who orders it. Gene analyses with an especiallyhigh predictiveness may only be carried out in those special facilities (laboratories) that areauthorised by the responsible Federal Ministry to carry out such gene analyses. Whenever agene analysis is carried out to diagnose a predisposition for hereditary diseases or aninfection status the GTG demands that a physician who is fully qualified in human geneticsprovides extensive medical advice to the affected person. Besides that, he should also pointout that it would be advisable to get additional medical advice provided by a psychotherapistor social worker. Human gene analyses for scientific or educational purposes are onlypermitted if the provider of the samples explicitly agrees in written form, or if these analysesare only carried out with anonymous samples (§ 66 para. 1). An exchange or publication ofthe results may only take place if the provider of the samples can't be determined. As to theuse of data from genetic analyses, the GTG (§ 71) regulates the data processing,confidentiality and intellectual property rights and obligations which go beyond theregulations concerning professional secrecy and the law on the confidentiality of data(Datenschutzgesetz). Employers and insurance providers are not allowed to collect,demand, accept, or use the results of gene analyses from their employees or from peopleapplying for a job. Human gene-therapy: Prohibition of any kind or germ-line therapy:


carefully directed genetic manipulation of the genetic material of human cells which will bepassed on to following generations.

Somatic gene therapy (§ 74 GTG) is only admissible if it is carried out for the purpose oftherapy, or the prevention of serious human illnesses, or during the course of a clinicalexamination that is done to establish appropriate procedures in this context. Only a physicianwho works in an especially licensed hospital is authorised to do this (§ 75 GTG). Humansomatic gene therapies during the course of a clinical examination have to be carried out inaccordance with the relevant regulations of the Pharmaceutical Products Act (Arzneimittel-gesetz) and furthermore, such a clinical examination may only take place with the consent ofthe responsible Federal Ministry (§ 76 GTG). The Federal Minister has to hear the ScientificCommittee for Human Gene Analysis and Gene Therapy and, if necessary, also the AdvisoryBoard for Pharmaceutical Products (Arzneimittelbeirat) (§ 77 GTG).

Sector IVa deals with the topic of Civil Liability. The Amendment of the Gene technology Act1998 includes an introduction of a civil liability of the notifier for personal and materialdamages, which may occur in connection with operations using GMOs in contained systemsor with their release, and which is independent of the actual cause (verschuldensunabhän-gige Gentechnik-Gefährdungshaftung, § 79a to § 79j Amendment of GTG). A facilitation ofevidence is provided for the affected party. The notifier may defend himself by proving thatthe damages were not caused by the genetically altered characteristics of the GMOs. Theinitiator of operations using GMOs in contained systems or of GMO releases has to get aninsurance or make some other provisions, in order to be able to deal with claims fordamages (provision for cover – Deckungsvorsorge). The Federal Government and the Statesare exempt from this responsibility to make provisions (to what extent this exemption alsoapplies to activities in University facilities still has to be clarified). If operations using GMOs incontained systems or GMO releases affect the environment to a point where they present arisk for human health and for the environment, the authorities have to compel the notifier torestore the environment and to prevent further damages.

Section V includes the structure and responsibilities of the Advisory Board on Genetechnology (Gentechnikkommission), the Book of Biotechnology (Gentechnikbuch), and theestablishment of permanent scientific committees of the Advisory Board on GeneTechnology. The Advisory Board on Gene technology as referred to in § 80 GTG consists ofrepresentatives from different scientific fields, various Federal ministries, social partners anddifferent social groupings (NGOs). The Advisory Board on Gene technology and its scientificcommittees is located within the competent Federal Ministry. The responsibilities of theAdvisory Board include (1) advising the competent authority on basic questions about theuse of gene technology, (2) making a decision on the proposed sections of the Book ofBiotechnology, as well as (3) drawing up a report on the use of gene technology (§ 84 GTG).The first report on the use of gene technology in Austria was presented in 1998 (cf.BKA/BMFV 1999). According to § 85 GTG, the Advisory Board on Gene technology is aidedby three permanent scientific committees: 1. committee for contained operations usingGMOs, 2. committee for releases and placement on the market, and 3. committee for humangene analysis and gene therapy. Their tasks include (1) the evaluation of notifications and


applications, (2) the preparation of various sections of the Gene technology Codex, and (3)presenting comments about ordinance drafts (§ 86, § 87, § 88 GTG). The competentauthority is responsible for the publication of the Book of Biotechnology as referred to in § 99GTG. In this codex, the Advisory Board on Gene technology documents the state of scienceand technology with regard to working with GMOs, the release of GMOs, and the placementon the market of products, as well as human gene analyses and somatic gene therapy. Theindividual sections of the Book of Biotechnology are proposed to the Advisory Board by eachresponsible scientific committee. According to the First Report of the advisory Board onGene technology (cf. BKA/BMFV 1999: 5) the scientific committee for gene-analyses andgene-therapy drew up a list of guidelines for gene-analyses, which defines the generallyaccepted, scientifically and technologically updated "requirements for the initiation andcarrying out of gene-analyses in accordance with § 65 para. 1 L 1 GTG, and for an institutionas referred to in § 68 GTG". The Advisory Board on Gene technology decided to include thisparticular section in the Gene technology Codex on January 23, 1998.

Table 16: Responsibilities of Authorities

Area of responsibility 1994-1997 Feb. 1997-April 2000 since April 2000

General affairs of theGTG

Federal Ministry ofHealth, Sports andConsumer Protection

Federal Chancellery /Minister of Women’sAffairs and ConsumerProtection – BKA/BMFV

Federal Ministry forSocial Security andGenerations –Bundesministerium fürsoziale Sicherheit undGenerationen – BMSG

Deliberate release ofGMOs of universities orother public scientificorganisations

Federal Ministry ofScience, Research andArt

Federal Ministry ofScience and Traffic –BMWV

Federal Ministry forEducation, Science andCultureBundesministerium fürBildung, Wissenschaftund Kultur – BMBWK

Consulting thecompetent authority inissues of the deliberaterelease of GMOs andthe placement on themarket of productsconsisting of, orcontaining GMOs

Federal Ministry of theEnvironment, Youth andFamily Affairs / FederalEnvironment Agency

Federal Ministry of theEnvironment, Youth andFamily Affairs / FederalEnvironment Agency –BMUJF/UBA

Federal Ministry ofAgriculture, Forestry,Environment and WaterManagement –Bundesministerium fürLand- undForstwirtschaft, Umweltund Wasserwirtschaft –BMLFUW

Section VI regulates the responsibilities of authorities in Austria, and the controllingmeasures according to § 100 GTG: During the legislation phase, the competencies for thearea of gene technology were located in the Federal Ministry for Health, Sports, andConsumer Protection (BMGSK). During the government re-shuffle in February 1997, theresponsibilities for gene technology and consumer protection were transferred to the FederalChancellery/Federal Minister for Women's Affairs and Consumer Protection (BKA/BMFV).Since the change of government at the beginning of year 2000 the general gene technology


affairs in the Gene technology Act are dealt with by the Federal Ministry for Social Securityand Generations – BMSG (starting in April 2000).

Dispersal of competencies: A problem which seems to result from the fact that within Austriadifferent Federal Ministries are responsible for the implementation of certain EU directives inAustrian law. The BKA/BMFV is responsible for the aforesaid EU directives on the work withGMOs in contained systems and on the release of GMOs into the environment; the BMAGSis responsible for EU directives on the protection of employees; the BMLF is responsible forthe labelling of seed products and finally the BMwA is responsible for the regulation of thepatent law.

Section VII regulates the furthering of a multi-layered risk and safety research (§ 102).Section VIII deals with preliminary compulsory measures or sanctions. Section IX covers theexpiration of the authorisation. Section X contains regulations of the confidentiality of datafrom the notification procedure. Section XI regulates the international exchange ofinformation and last but not least, Section XII covers temporary, penal, and final provisions.

EU Conformity of the Gene technology Act – GTG

§ 63 GTG Social unsustainability: In terms of EU compatibility § 63 GTG also presents aproblem. Article 15 of the Release Directive states that the member states may not prohibit,restrict or impede the placement on the market of a product containing or consisting ofGMOs as long as it complies with the regulations in this directive. One reading of Article 15of the Deliberate Release Directive (cf. Waldhäusl 1995: 22) proceeds from the assumptionthat this prohibition is only applied in view of the aspects that are mentioned in the ReleaseDirective. Therefore the Release Directive would only represent a partial harmonisation ofthe legal area concerned. Measures to restrict the placement on the market of GMOproducts for any other reason (i.e. aspects other than the protection of human health and theenvironment) are thus basically allowed in the member states. This means that theestablishment of ethical criteria in the broadest sense – including the social incompatibilityclause in the GTG – is basically admissible within the context of the general requirements ofthe Council of Europe. However, there are some problems regarding the limitation ofcompetencies in Article 30 of the EU Treaty which refers to the guarantee and realisation offree movement of goods within the European market.

As opposed to that, Loibl/Stelzer (1997) propose in their legal examination of § 63 GTG in1997, that on a European level a certain movement may be detected from a horizontalregulation such as the Release Directive towards vertical harmonisation measures, wherebythe so-called "one-door, one-key" principle shall be applied. There are several examples forthis: Directive on Novel Food, Pharmaceutical Products or Plant-Protective Agents/Pesticides. Even though Article 15 of the Release Directive is not clearly defined, Loibl/Stelzer (1997: 50) interpret it – by taking the Commission decisions on the authorisation ofindividual products as referred to in the Release Directive into consideration – this in a waythat makes them believe that, on the one hand with regard to GMOs it contains adefinitive/exclusive regulation, but on the other hand with regard to product regulations it


does not. The fact that this procedure can only examine aspects of safety, protection ofhealth and environment can lead to the assumption that the hitherto existing exclusion ofother aspects, as for instance social incompatibility, may rather be understood as adeliberate political decision. The Release Directive presents a definitive directive onharmonisation, which leads to the fact that the social incompatibility clause as referred to in§ 63 GTG does not comply with EU law (cf. Loibl/Stelzer 1997: 52). However, Torgersen/Nentwich/Seifert (1997/1998: 27 footnote 7) argue that Loibl's/Stelzer's interpretation isbased on the assumption that the legal actions of the European Court of Justice should beseen as a full harmonisation, and that this can't be taken for granted due to a lack of relevantEuCJ judicature.

Import ban on GM-maize: Up to this point there are no legal opinions on the EU conformity ofthe two import bans on GM-maize of Novartis (original of Ciba-Geigy, VO Nr. 45/1997,BKA/BMFV) and of Monsanto (VO Nr. 175, 1999, BKA/BMFV). In Loibl's and Stelzer's legalopinion, which generally focuses on the national action range of Austrian legislation in thelegal regulation of the use of gene technologies, indications may be found of the Europeanlegal assessment of the import ban (cf. Loibl/Stelzer 1997: 35-39). The deliberate releaseand placement on the market of products requires the same procedure throughout theCommunity (Article 7 and Article 11 of the Release Directive 90/220/EEC). As to theplacement on the market, the other member states don't just have the right to comment uponthe matter but also to raise objections which have to be taken into consideration by theCommission. The member states are asked to voice their concerns in a community-wideprocedure where they may raise well-founded scientific objections. The Commission isobliged to take these objections into consideration before they make a decision. Generally,the directive follows the principle that once a product has received a written consent it maybe traded and used throughout the Community, as long as the conditions of use are adheredto. However, if a member state has justifiable reasons to believe that a product which hasbeen properly notified and has received written consent presents a risk to human health andthe environment, it may provisionally restrict or prohibit the use or sale of this product on itsterritory. The Commission and the other member states have to be informed of such actionwithin three months. The Commission has to decide whether this measure is justified(Article 16 of the Release Directive). Austria has taken this opportunity laid down in Article 16of the Release Directive in both cases of the import ban of GM maize. The decision by theCommission and the European Court of Justice respectively, whether Austria had justifiablereasons to do this, or whether Austria violates EU law, is in both cases still pending.

1.4.2 Investment Capital

The size of the Austrian private equity industry is very small in European comparision (cf.Diagram 3) and "out of the line with Austria's general economic position" (EVCA 1999: 46).Austria is last but one by its share of private equite investment on GDP (1998) incomparision with other countries participating on the EBIS project (cf. Diagram 3).


Diagram 3: Private Equity Investment as % of GDP in 1998

0,585

0,3140,185 0,139 0,102 0,087 0,076 0,027 0,018

UK NL Europe F D IRL SP A GR

Source: EVCA 1999: 21

In 1998, the main investors in private equity were banks (39.7%), government agencies(23.0%) private individuals (18.8%) and corporate investors. Investments of realized capitalgains, insurance companies were less important. In its investor structure of private equityAustria differs remarkably from the European pattern: While the share on investment frombanks, government agencies, private individuals and corporate investors is higher than inEurope as a whole, the share of investment from realized capital gains, insurancecompanies and particularly from pension funds is remarkably lower than in Europe as awhole (cf. Diagram 4).

Diagram 4: Comparison of Private Equity Raised by Type of Investor in 1998(Austria/Europe)

39,723,0 18,8 15,2

0,7 0,5 0,1

27,85,1 7,6 9,8 8,8 8,9

24,0

Banks GovernmentAgencies

PrivateIndividuals

CorporateInvestors

RealisedCapital Gain

InsuranceCompanies

PensionFunds

Austria Europe

Source: EVCA 1999: 11 and 48

In 1998 24.4% of investments from private equity were made in start-ups, a form ofinvestment which is particularly relevant for young biotechnology companies (cf. Table 17).

Out of the 9 full and associate members listed in the Yearbook 1999 (EVCA 1999: 2ff.) threehave an explicit industry preference in biotechnology (Global Equity Partners, HorizonteVentrue Management GmbH, Innovationsagenur GmbH). In 1997 no investment inbiotechnology was made. In 1998 two investments were made in two companies totallingwith EURO 1.8 Million, i.e. 3.6% of all investment in terms of amounts, 2.4% in terms of thenumber of investments and 2.6% in terms of the number of companies (EVCA 1999: 50).According to a manager of an Austrian private equity firm in Austria there are two venturecapital companies active in high-risk investment in biotechnology (personal communicationwith Horizonte, June 24th, 1999).


Table 17: Stage Distribution of Investment of Private Equity in Austria in 1998

Amount of investment in EURO %

Seed 0 0

Start-Up 12 330 182 24.4

Expansion 23 990 247 47.5

Replacement Capital 0 0

Buyout 14 183 412 28.1

Total 50 503 841 100.0

Source: EVCA 1999: 50, ECU converted to EURO


2 Biopharmaceuticals

The following section will outline the relative importance of the pharmaceutical sector inAustrian and European perspective. Subsequently, Austrian data will be compared withfigures from other countries participating in the EBIS project. Several indicators will be usedto answer the following questions: (1) What is the relative importance of Austrianpharmaceutical industry in European perspective? (2) What is the relative importance ofAustrian pharmaceutical industry in comparison to other industrial sectors?

We will start to answer these questions by looking at the production of the pharmaceuticalindustry in general in the EBIS partner countries from 1992-1994 (cf. Diagram 5).

Diagram 5: Pharmaceutical Production in MECU, Purchase Power Parity (PPP)(1992-1994)22

0

5.000

10.000

15.000

20.000

D F UK SP NL A GR

1992 1993 1994

Source: OECD Health Data 1998

Despite the fact that the last available figures are from the early 90s, Diagram 5 gives ageneral idea of Austria's comparatively small pharmaceutical production in absolutenumbers. Out of seven EBIS-partner-countries, Austria is last but one before Greece.

In contrast to its low total production in European perspective the Austrian pharmaceuticalindustry is rather productive. Austria is third out of seven of EBIS partner countries whencomparing the pharmaceutical production per capita (cf. Diagram 6).

Another indicator to assess the relative size of the Austrian pharmaceutical industry is thenumber of employees (cf. Diagram 7).

22 No figures for Ireland available in the database.


Diagram 6: Pharmaceutical Production in EBIS Partner Countries per Capita ECU,PPP (1994)23

239 226 219188 182 169

58

F UK A SP D NL GR


Diagram 7: Pharmaceutical Industry Employees (Thousands of Persons) (1994)24

104 101

74

40

15 10 9 7

D F UK SP NL IRL A GR

Source: OECD-Health Data 1998

Diagram 7 illustrates that the Austrian pharmaceutical industry is also small in terms ofemployment. Again Austria is last but one out of all EBIS partner countries. German andFrench employment figures are more than ten times higher than those of Austria. ThusAustria in terms of the availability of a critical mass, is in a comparatively modest competitiveposition in European perspective.

Like the Netherlands, Spain and Greece, Austria is a net-importer of pharmaceuticals (cf.Diagram 8). This feature did not change in recent years although both imports as well asexports expanded (cf. Diagram 9).

23 Data for UK, NL and GR 1993; no Irish figures available in the database.24 Data for UK 1995, NL 1993, IRL 1995, GR 1992


Diagram 8: Pharmaceutical Industry (Manufacturing) Imports and Exports MECUPPP (1994)25

exports 5797 5633 4350 1524 1015 748 79

imports 3151 3586 3062 2178 1786 975 720

UK D F NL SP A GR


Diagram 9: Pharmaceutical Industry (Manufacturing) Imports and Exports ECU PPPper Capita in Austria 1985-1994

42 42 40 46 5363

73 78 8293

56 57 63 6675

8797

106115 121

020406080

100120140

1985 1986 1987 1988 1989 1990 1991 1992 1993 1994

Pharma-Exporte, Industrie - Ecu KKP pro Kopf Pharma-Importe, Industrie - Ecu KKP pro Kopf


How important is Austria's pharmaceutical industry in comparison to other sectors? Oneindicator with which we tried to approach this question is the relative share of pharmaceuticalindustry on total employment (cf. Diagram 10).

The diagram shows that the share of pharmaceutical industry on total employment variesacross Europe. Ireland ranks first with an extraordinary high figure - followed by France,Spain, Germany and the UK. Austria is fifth out of the eight EBIS partners. Although thedifferences between Austria, the UK and Germany are not that big, the Austrian employment-figure is still lower than in many EBIS-partner countries. This might be considered as anotherindication of the small importance of the pharmaceutical industry in international comparison.

25 Data for Greece and Netherlands 1993; no data for Ireland available in the database.


Diagram 10: Pharmaceutical Industry Employees: Share on Total Employment(1994)26

0,81

0,460,33 0,30 0,28 0,25 0,22 0,19

IRL F SP D UK A NL GR

Source: OECD-Health Data 1998

Another indication of this minor importance is the fact that among the 500 biggest Austriancompanies (measured by turnover made at the home market, cf. Pharmig 1998: 18) there isno pharmaceutical enterprise with an Austrian branch office.

In summary, the Austrian pharmaceutical industry is of only minor importance in Europeanperspective (cf. also Jörg et al. 1995: 114; Rosian et al. 1998: 82). Despite its comparativelyhigh productivity, the production of the pharmaceutical industry is small in comparison withmost EBIS partner countries. The Austrian pharmaceutical industry employs less people thanmost EBIS partner countries. This fact must be born in mind when considering thecompetitive position of Austrian industrial biopharmaceutical research and the necessarycritical mass. Also the share of pharmaceutical industry on total employment is smaller thanin five EBIS partner countries. Austria is a net-importer of pharmaceuticals and its industryconsists mainly of small and medium sized enterprises.


2.1.1 Public Funding Organisation

Public funding organisations financing biopharmaceutical research between 1994 and 1998are the BMWV, the FFF, the FWF, the ÖNB, the Innovation Agency, the City of Vienna, andwith comparatively small amounts several other Austrian provinces. The aims and activitiesof these public funding organisations and charities are described in chapter 1.3.1.

2.1.2 Research Organisations

A questionnaire was sent out to 102 research institutes. The names of the institutes originatefrom various lists from the BMWV, the BIT, the Austrian Society for Genetics and

26 Data for UK 1995, NL 1993, IRL 1995, GR 1992


Biotechnology (ÖGGGT) and from information during interviews. The institutes were askedto group themselves into the following research areas: biopharmaceutical research, agro-food, equipment and supply, environment, others (note: it was possible to decide for morethan one research area). After several reminders by telephone, ultimately 78 institutesresponded to the questionnaire, i.e. a respondent rate of 77%. 35 of the responding institutes(45%) were active in modern biotechnology.

It is striking that these numbers are by far much smaller than the findings of two recentstudies on the number of Austrian research organisations working in the field ofbiopharmaceuticals (Rosian et al. 1998; Clement et. al 1998). Rosian et al. found 44 publicsector research institutes and Clement et al. identified 61 research institutes in the Viennesearea alone. It is difficult to explain why only such a low number of institutes reported activitiesin biopharmaceuticals (given that the names of the institutes originated from competent lists).One explanation is that these lists are simply outdated and include many institutes which areno longer active in this field. Another explanation is the reluctance of institutes to make theirbiotechnology activity public given the low acceptance of biotechnology in the Austrianpopulation. However, it is beyond the scope of this project to test these two hypothesises.

Most of the institutes active in biotechnology were working in the field of biopharmaceuticals(22 institutes). 19 of these institutes are university research institutes, two are public sectorresearch institutes and one is a private research institute.

Most of these research institutes (12) are located in Vienna, namely at the University ofAgriculture (2), the University of Vienna including clinics at the university hospital (7), theTechnical University (2), the University of Veterinary Medicine (1) and a Ludwig BoltzmannInstitute located at the University of Vienna. Two institutes are located around Vienna, i.e. theIFA-Tulln and the Austrian Research Centre Seibersdorf. Five research institutes are locatedat the University of Innsbruck. Three research institutes are located in Graz at the TechnicalUniversity (1), the University of Graz (2) (cf. Table 18).

All of the 22 research institutes active in biopharmaceuticals were involved in fundamentalresearch. A number of these research institutes was also active in research fields other thanbiopharmaceuticals: Seven of them were also active in research in agro-food, two inequipment and supplies, three in environmental research, and two in biomedicine.

Table 18: Research Institutes Active in Biopharmaceutical Research by Location

Location Number of institutes

Vienna 12

Niederösterreich (vicinity of Vienna) 2

Innsbruck 5

Graz 3

Total No. of Institutes 22



The 22 research institutes active in biopharmaceuticals employ in total a scientific personnelof 815 people (full-time equivalent) of which 617 (76%) are active in biopharmaceuticals.Measured by scientific personnel, most research institutes dedicated to biopharmaceuticalsare small and medium sized (cf. Table 19).

Table 19: Number of Institutes by Number of Researchers Dedicated toBiopharmaceuticals (1999)

No. of Researchers 1-5 6-10 11-30 35-50 50-100 +100

No. of Institutes 8 4 3 2 1 1


Eight institutes employ between 1 and 5 researchers dedicated to biopharmaceuticals, fourinstitutes between 5 to 10, three institutes between 11 and 30, two institutes between 35 and50 and one research institute 60 researchers. One research institute employs a scientificstaff of 362 people working on biopharmaceuticals. From four institutes there was no dataavailable.

Between 1994 and 1998, the responding institutes granted a total of 135 firstuniversitydegrees and 124 PhD degrees for topics relating to biopharmaceuticals (cf. Table 20).

Table 20: Number of First-University Absolvents and PhDs in Biopharmaceuticalsin the Responding Institutes (1994-1998)

1994 1995 1996 1997 1998 Total

First 36 17 39 20 23 135

PhD. 27 20 19 24 34 124


21 of all the 22 institutes working in the field of biopharmaceuticals reported co-operationswith domestic and/or PSR-research institutes and firms.

2.1.3 Share of Total Biotechnology Research Funds Allocated 1994-1998

It is hard to give exact numbers for the amount of money spent on biopharmaceuticals inAustria, for many funding organisations do not break down their funding by the three sectors(e.g. FFF, BMWV). Funding organisations which did, however, that were the FFF (byapproximation), the Innovation Agency and the Provinces of Vorarlberg and Vienna (byapproximation). Taking only these numbers into account, public funding organisationssupported R&D in biopharmaceuticals between 1994 and 1998 with at least ca. 52 MioEURO – which is 69% of all biotechnology funding (cf. chapter 1.3.1).


Breaking down its biotechnology funding by sectors, the most important funding organisationis the FFF (77%), followed by the Community of Vienna (13%), and the Innovation-Agency(1.4%). The ÖNB does not break down their funding by the three sectors either, but it issound to assume from its priority in medicine that its funding can be attributed to biopharmain the wide sense (7.4%). These numbers, however, neglect and underestimate the role ofthe FWF and the BMWV, which are among the most important organisations when regardingfunding fundamental research in biotechnology in Austria. The following section will firstdescribe the role of the public funding organisations which break down their biotechnologyfunding by sector and will then describe the organisations which do not (cf. chapter 1.3.1).

Between 1994 and 1998, the FFF (cf. chapter 1.3.1) funded 116 biotechnology projectsamounting to 44 Mio EURO. According to the responsible person, ca. 90% of the funding isdedicated to biopharmaceuticals (ca. EURO 39.6 Million).

The City of Vienna concentrates its biotechnology funding on biopharmaceuticals. Between1995 and 1999, the Wiener Wirtschaftsförderungsfonds funded projects relating tobiopharmaceuticals totalling ca. 6.9 Mio EURO (cf. chapter 1.3.1).

The Innovation Agency (cf. chapter 1) supported in 1998 a biotechnology company withEURO 727 000 within its Biotechnology-Impulse-Programme. The province of Vorarlbergfunded in 1997 a small project in biopharmaceuticals with EURO 56 000.

The Ministry of Science and Transport does not break down its funding activities butsupported biotechnology with a number of initiatives (cf. chapter 1.3.1).

The Anniversary Fund of the Austrian Nationalbank (cf. chapter 1.3.1) supported between1994 and 1998 at least 162 biotechnology projects with ca. 3.8 Mio EURO. It is not clear towhich extent these project are dedicated to biopharmaceuticals, however, it is sound toassume that a relatively high share gave the focus of the Fund on medical research.

Furthermore, several Austrian provinces supported biotechnology within their generalactivities in subsidising economic development. It can be assumed that within these activitiesthey also supported companies active in biopharmaceuticals, though it is not clear to whichextent because they do not break down their funding in biotechnology sectors (cf. chapter1.3.1).

2.1.4 Special Programmes for University/Industry Research Collaboration

In general, all programmes aiming at university/industry research collaboration described inchapter 1.2.2 are relevant for the biopharmaceutical sector. In particular, the projects of theFFF, the City of Vienna and the Innovation Agency described in chapter 2.1.3 are aiming atuniversity/industry collaboration and are relevant in this respect.


2.1.5 National Involvement in Framework Programmes

Table 21 provides an overview on the National involvement in Framework programmesrelevant to biotechnology.

Table 21: National Involvement in Framework Programmes Relevant toBiotechnology

Programme Total of projects Austrian participation Austrian coordination

Proposed Successful Proposed Successful Proposed Successful

Biomed 3702 686 554 104 90 11

Biotech 2125 506 192 46 46 9

Source: BIT, Bureau for International Research and Technology Co-operation, Info sheet 1999

Austrian researchers participated in 104 Biomed Programmes and 46 Biotech Programmesas well as coordinated 11 Biomed Programmes and 9 Biotech Programmes.

Within the 18 programmes of the Fourth Framework Programme (FP4), which runs fromDecember 1994 to December 1998, BIOTECH II is the most relevant to life sciece.BIOTECH II has EURO 595 Mio available and encourages links between fundamentalresearch and industrial applications. BIOMED II, which has EURO 374 Mio available, isfocussed on the field of biomedicine and health (Ernst &Young 1998: 77).

2.2 Industrial Structure

A questionnaire was sent out to 87 companies which were identified by using various listsfrom the BMWV, the BIT, the BWK, the Chamber of Commerce and suggestions madeduring interviews. All firms received all three questionnaires and were asked to fill in thesector, they consider appropriate for them. After several reminders by telephone 57companies responded to the questionnaire, i.e. a response rate of 66%. 31 of the respondingcompanies (37%) were active in modern biotechnology. Most of these companies, i.e. 13(61%) were active in biopharmaceuticals.

Again it is difficult to explain the low number of firms from competent lists which reportedbiotechnology activities. But probably the same hypothesises which might explain the lownumber of biotechnology institutes in comparison the to number of institutes addressed canalso be assumed for the low number of biotechnology firms.


2.2.1 Firm Characteristics

Out of the 21 Austrian companies active in modern biotechnology responding to thequestionnaire 13 (ca. 62%) are active in biopharmaceuticals. These companies are – with afew exceptions – mostly small and medium sized enterprises. 5 companies employ between5 and 20 people, one between 21 and 50, one between 51 and 100, two between 101 and500 and four companies employing more than 500 people (cf. Table 22).

Table 22: Number of Firms Dedicated to Biopharmaceuticals by Number ofEmployees (1999)

No. of Employees 5-20 21-50 51-100 101-500 +500

No. of Firms 5 1 1 2 4


Five of the responding companies employed between 1 and 10 people in R&D, threebetween 11 and 50, three between 151 and 200 and two companies 304 and 485 peoplerespectively.

Three companies were founded in the 40s and 50s, two in the early 70s and 3 between 1984and 1987. Four companies were founded in the 90s, three of them between 1997 and 1999.

One company reported being a university spin-off, two that they were company spin-offs andseven that they were independently established. One company declared to be a subsidiaryof an international research conglomeration and two that they were both, company anduniversity spin-offs.

Six companies were active in product research, twelve in product development and seven intechnology development. Eleven of these companies had at least one biotechnology producton the market and two companies had enabling technologies on the market. Eightcompanies were also offering services. Six companies offered contract research and fourothers offered services (co-production, contract production, contract sample sets ofmeasurement).

Three companies had products in test-phase I (one, two and 12 products respectively). Theco-operation partners for these tests are European and national. Two companies had aproduct in test-phase II (two and five products each) and two companies had products intest-phase III (2 and eight products each).

The firms are active in the following fields:

- Recombinan tproteins 9- Monoclonal antibodies 8- Vaccines antibodies 7


- Diagnostics 6- DNA protein synthesis 6- DNA protein sequencing 6- Bioinformatics 6- Model animals 5- Blood products 5- GENOMICS 4- Transgenics 4- Molecula rmodelling 4- Genetherapy 3- Combinatorial chemistry 3- HTS 3- Antisense 1

2.2.2 Dominance of National, European, US or Rest of World Owned Firms

There is almost no pharmaceutical industry of Austrian origin (van den Berg et al. 1999:259). The large share of Austrian biopharmaceutical firms is part of multi-national combines.Out of the 21 manufacturing firms, which Rosian et al. could identify in their research, fiveare in Austrian possession. Five firms are branch offices of German combines, three firmsare US-owned, and two in Swiss or Swedish possession respectively (Rosian et al. 1998:53).

2.2.3 Total Turnover of Sector and Source

Three firms had a turnover between 200.000 and 1 Mio EURO. Five had a turnover between1.1 Mio EURO and 10 Mio EURO and two had a turnover of 510 and 650 Mio Eurorespectively. The biotechnology share on total turnover varied between 6 % and 100 % withone firm under 10 %, three between 20% and 35% and 5 firms with 100% (3 firms did notstate their biotechnology share on turnover, IHS Survey 1999/2000).

2.2.4 Main Geographic Market

Austrian firms active in biopharmaceuticals are export-orientated. Only one firm consideredthe domestic market as most important for its products, two Europe and the US respectivelyand five the world market. The main market for services of these companies is Europe (3),followed by USA (2) the domestic market (2) and other countries (1). Seven firms wereconducting clinical trials for themselves.

2.2.5 Source of Technology

The survey provides only little information on source of technology since only two firms filledout this question.


2.2.6 Main Suppliers to the Sector

Given the small equipment sector in Austria, the main suppliers to the sector are foreign. (cf.chapter 4).

2.2.7 Research Collaborations

Research co-operations of responding biopharmaceutical firms show the following patterns(cf. Table 23 and 24).

Co-operation firm/PSR

Table 23: Number and Origin of R&D Co-operations of Responding Firmswith PSR

Co-operation with partners inNo. of firms with co-operation in

a particular regionNo. of co-operations

Austria 11 42

Europe 9 59

US 6 41

Other countries 5 5


12 countries reported R&D co-operations with private or public sector research. However,co-operations between firms and PSR are more frequent then firm-firm co-operations andthese follow different patterns.

Co-operations firm/firm

Table 24: Number and Origin of R&D Co-operations of Responding Firms withOther Firms

Co-operation with partners inNo. of firms with co-operation in

a particular region No. of co-operations

Austria 7 16

Europe 12 33

US 10 49

Other countries 1 2



11 firms had a co-operation with PSR in Austria, 9 firms with European research institutes, 6with US-American research institutes and 5 with institutes in other countries. These 11 firmshad in total 116 co-operations with PSR. The majority of PSR co-operation is carried out withEuropean institutes (59) followed by Austrian institutes (42) and US-American institutes (41).

12 responding firms reported co-operations with other firms. Firm/firm co-operation is lessfrequent than co-operation with PSR institutes, and has its main focus clearly on co-operation with foreign firms: US (49), European (33).

In summary, the responding firms are integrated in domestic and international researchnetworks. However, co-operation with PSR is more frequent than firm/firm co-operation. Co-operation between firms is even more internationally orientated than co-operation with PSRinstitutes.

2.2.8 Business Interest Non-Government Organisations (BINGOs)

Pharmig is a lobby group on voluntary basis of producers and distributors of pharmaceuticalsunder the Austrian Medicament Law, covering various pharmaceuticals such as veterinarymedicine, homoeopathic medicine, allopathic medicine, biotechnology and phytopharmicmedicine. Pharmig represents 106 pharmaceutical enterprises in Austria – that is 97% to98% of all pharmaceutical enterprises. Pharmig has the following tasks: (1) lobbying in thepolicy making process at Ministries and the Parliament, (2) public relations concerning topicssuch as biotechnology, animal testing, prices of medicaments, (3) information platform formembers, that is, providing information as well as taking up concerns of members andbringing them to policy. Pharmig has the following goals towards biotechnology: Expansionof Austria as a location of biotechnology (enlisting of foreign companies, expansion of Austriaas a location of R&D to secure jobs), to create even better conditions for research inbiopharmaceuticals, to make the most of the human potential available in Austria (to avoidbrain-drain) (personal communication with Pharmig, December 15th , 1999).

2.3 Consumer Attitudes and Market Demand

2.3.1 Market Size and Specific Characteristics

The most important users of biopharmaceuticals are Austrian hospitals who use 53 % of allbiopharmaceutical drugs licensed in Austria. The remaining 47% is prescribed by physiciansin ambulatory care (Rosian et al. 1998: 46). An apparently important market characteristic ismarket volume. OECD-statistics (cf. Diagram 11) show a considerable variation of totaldomestic markets for pharmaceuticals across Europe. French total domestic market percapita is more than four times the Irish figure. Austria ranks third out of all EBIS partnercountries.


Judging from Diagram 11, Austria has a rather well developed domestic market forpharmaceuticals (in terms of relatively high demand per capita in European perspective). Incase of biopharmaceuticals this demand is mainly covered by imports (cf. e.g. Rosian et al.1998: 114).

Diagram 11: Total Domestic Market for Pharmaceuticals per Capita ECU PPP (1996)27

269 247216 204

175 164145

82

F FRG A GR SP NL UK IRL


In this section the following questions will be answered:

1. How many biotechnology pharmaceuticals are licensed/available in Austria?2. How did the market for biotechnology pharmaceuticals develop since 1982?3. How much money did health insurance companies and hospitals spend on

biotechnology pharmaceuticals?4. What is the size of the market for biopharmaceuticals?

In their study Rosian et al. (1998: 34) investigated the number of biotechnologypharmaceuticals licensed and available in Austria. They searched for "therapeutics, vaccinesand in-vitro diagnostics which are produced by biotechnological processes and used inhuman medicine". They distinguished between "other biotechnological pharmaceuticals"processed with micro-organisms and "gene-technological pharmaceuticals" produced bygene technological processes.

In July 1997 8 352 pharmaceutical products were licensed for human medicine in Austria.7 367 of these products were non-biotechnology (NBT) products (88.2%), 204 (2.3%) weregene technological (GT) products and 781 (9.4%) were other biotechnological (OBT)products (cf. Diagram 12). 93% of the pharmaceuticals are for therapeutics, 6% vaccines,1% in vivo-diagnostics.

The number of NBT pharmaceuticals, OBT pharmaceuticals and GT products increasedbetween 1982 and July 1997 (cf. Table 25).

27 Data for Greece 1994


Diagram 12: Pharmaceuticals Licensed in Austria (July 1997)

2%9%

89%

gen-technologicy other biotechnology non-biotechnology

(data from Rosian et al. 1998: 35)

The share of biotechnological pharmaceuticals on all pharmaceuticals increased since 1982from 8.4% to 11.8%. This increase happened in the context of an overall growing supply ofdrugs. However, the supply of all biopharmaceuticals grew faster than of NBT drugs:Whereas between 1982 and July 1997 the number of all pharmaceuticals increased by197%, the number of NBT pharmaceuticals increased slightly slower (186%). In contrast thenumber of OBT pharmaceuticals increased faster (230%) and GT pharmaceuticals increasedfrom 1 to 204 products.

Table 25: Pharmaceuticals for Human Medicine by Production Method1982-July 1997

Year Number of Drugs Share on all Drugs in %

Biotechnology Biotechnology

GT OBT NBT GT OBT NBT

1982 1 236 2 575 0.0 8.4 91.6

1985 14 303 3 009 0.4 9.1 90.5

1988 43 362 3 410 1.1 9.5 89.4

1991 87 482 4 425 1.7 9.7 88.6

1994 134 652 5 897 2.0 9.8 88.2

1995 147 721 6 475 2.0 9.8 88.2

1996 171 762 7 038 2.1 9.6 88.3

July 1997 204 781 7 367 2.4 9.4 88.2

(Rosian et al. 1998: 38)

How much money was spent on biopharmaceuticals in Austria? Table 26 shows the averagegrowth of prescriptions and expenses between 1990 and 1996 billed by health insurancecompanies.


Table 26: Number of Prescriptions and Associated Expenses of Health InsuranceCompanies for Pharmaceuticals 1990-1996

YearPRESCRIPTIONS(Index 1990 = 100)

EXPENSES(Index 1990 = 100)

Biotechnology All Pharmaceuticals BiotechnologyAll

Pharmaceuticals

GT OBT GT OBT

1990 100.0 100.0 100.0 100.0 100.0 100.0

1991 109.2 106.1 104.1 125.9 106.2 109.9

1992 119.7 116.4 108.9 162.1 114.7 122.6

1993 140.6 127.8 111.4 226.2 126.8 134.7

1994 163.4 126.7 113.9 282.6 127.4 145.9

1995 185.9 137.2 116.5 300.1 148.5 153.6

1996 201.8 137.1 114.8 362.3 160.8 163.2


Whereas the number of prescriptions and expenses of all pharmaceuticals increased in thetime span between 1990 and 1996, the growth of those for GT pharmaceuticals wasespecially dynamic: the number of prescriptions doubled and expenses more than trebled.Diagram 13 illustrates this development.

Diagram 13: Expenses of Health Insurance Companies for Pharmaceuticals1990-1996

100126

162

226283 300

362

100

161

100 127 127 149

163154145135

-30

70

170

270

370

1990 1991 1992 1993 1994 1995 1996

gene-technology other biotechnology all pharmcaceuticals


The dynamic growth of GT pharmaceuticals also shows in the average annual growth rate ofprescriptions and associated expenses of health insurance companies: Whereas the numberof prescriptions for all pharmaceuticals increased between 1990 and 1996 on the average by2.3 % each year, the respective figure for OBT pharmaceuticals was 5.4% and for GT


pharmaceuticals 12.4%. Expenses for all pharmaceuticals increased on the average by 8.5%every year, OBT pharmaceuticals by 8.2% and GT pharmaceuticals by 23.9%.

What is the size of the market for biopharmaceuticals? Diagram 14 illustrates the share ofbiopharmaceuticals on total turnover of pharmaceutic firms.

Diagram 14: Share of Biopharmaceuticals on Total Turnover of Pharmaceutic Firms(Wholesale Prices)

6%

19%

75%

gene-technology other bio-technology non-biotechnology


The estimated total turnover of pharmaceutical products for human medicine in 1996 was1 257 MECU (based on wholesale prices). About 25% of all pharmaceuticals werebiotechnological – that amounts to about 312 MECU. 6% of the total turnover were madewith gene-technological drugs and 19% with other biotechnological pharmaceuticals. 23%(ca. 73 MECU) of all biotechnology pharmaceuticals were GT pharmaceuticals and 77% (ca,240 MECU) were OBT pharmaceuticals.

Based on consumer-prices the share of biopharmaceuticals amounts to 17%, 4% GTpharmaceuticals and 13% OBT pharmaceuticals.

GT pharmaceuticals are on the average more expensive than NBT pharmaceuticals andOBT pharmaceuticals and their costs rise more quickly (cf. Table 27).

In 1996, the total expenses for biopharmaceuticals were 137.6 Mio EURO. In 1996, anaverage prescription for GT pharmaceuticals was six times more expensive than OBTpharmaceuticals and more than 8 times more expensive than an average prescription for allpharmaceuticals. In addition, the expenses for average prescriptions of GT pharmaceuticalsincreased more rapidly between 1990 and 1996: GT pharmaceuticals increased by 180%,OBT pharmaceuticals by 117% and all pharmaceuticals together by 142%.


Table 27: Average Expenses of Health Insurance Companies per Prescription(in EURO)28

Year Biotechnology All Pharmaceuticals

GT OBT

1990 56.46 13.90 8.82

1991 63.16 13.91 9.31

1992 76.46 13,69 9.93

1993 90.84 13.79 10.66

1994 97.69 13.96 11.30

1995 91.15 15.04 11.63

1996 101.38 16.30 12.53


2.3.2 Regulation Policy

Regulations with particular importance for biopharmaceuticals are the Austrian Drug Law(Arzneimittelgesetz, AMG, BGBl. 185/83 i.d.F. 379/96) and the European regulation (EWGNr. 2309/93) (cf. Rosian et al. 1998: 20 ff.).

The Austrian Drug Law defines what is considered as drugs. Accordingly the term "drug"includes drugs, vaccines and in vivo- diagnostics (for both humans as well as animals, cf.Rosian et al. 1998: 20 ff.).

According to the European regulation (EWG) Nr. 2309/93 Austrian drugs can be licensed bythree procedures, i.e. centralised, decentralised and nationally. In this Austria does not differfrom other EU-Member States. In the centralised procedure, drugs are directly licensed bythe European Agency for the Evaluation of Medicinal Products (EMEA) in London. The de-centralized licence procedure, which is used for all drugs which are not obligatorily oroptionally licensed by the centralised procedure, builds upon the national acknowledgementof national licenses from other EU-Member States. A purely national license procedure isonly possible if a drug is only available on the Austrian market (cf. Rosian et al 1998: 20 ff.).

According to experts from the Austrian Federal Institute for Health Care (ÖsterreichischesBundesinsitut für Gesundheitswesen, ÖBIG) the umbrella organisation of Austrian ObligatoryHealth Insurances (Hauptverband der österreichischen Sozialversicherungsträger) andpharmaceutical companies negotiate directly about the prices of a particular product. In caseof a conflict, a commission within the BMAGS acts as mediator. According to these experts,the Hauptverband der österreichischen Sozialversicherungsträger in principal welcomesinnovative products, despite the fact that they are more expensive. The policy of the

28 1 EURO = 13.7603 ATS


Hauptverband is to promote the use of generica and to use the savings for more expensivedrugs (personal communication ÖBIG, December, 1st 1999).

2.3.3 Public Interest Non-Government Organisations (PINGOs)

At present, about 600 autonomous self-help groups are working in social and health care(Fonds Gesundes Österreich, http://www.fgoe.org/selbsthi.htm). Many of them have semi-professional structures and are working on a regional and national level, others are onlyworking on the local level and are primarily aiming at directly supporting individual patients.Due to their different structures and objectives, self-help groups are very different from eachother. Patient self-help groups do not provide services for patients. According to theestimation of an expert from the Fonds Gesundes Österreich, the porfolio of the Austrianpharma industry is determined primarily by consideration on an international level and wouldleave no space for local self-help groups to influence R&D decisions of pharmaceuticalindustry (personal communication with Fonds Gesundes Österreich, July 24th, 2000).

2.3.4 Case Study of Controversy: Xenotransplantation

The question, whether there is a public controversy about xenotransplantation in Austria canbe simply denied. There is neither a public discussion (let alone a controversy) in theAustrian media, nor do other forms of public debate exist between supporters and opponentsof xenotransplantation. The study on the Austrian xenotransplantation discussion willtherefore ask three questions: Which factors are responsible for the absence of acontroversy? What are the positions of actors of a potential controversy? Will there be acontroversy on xenotransplantation in the future in Austria?

Why is a controversy on xenotransplantation non-existent in Austria?

Several reasons might be responsible for the existence and intensity of a controversy onxenotransplantation in a specific country. One way to categorise them is to distinguishbetween supply side factors, demand side factors and factors which refer to thecharacteristics of public debate on scientific issues in a particular country. One importantsupply side factor is public and/or industry research in xenotransplantation, which push forapplication. An important demand side factor is pressure for xenotransplantation because ofthe shortage of transplants from human donors.29 Important factors which relate tocharacteristics of public debate on science in specific countries are e.g. theinstitutionalisation of discursive arenas in which controversial scientific issues can bedebated, the intensity and content of media coverage on science, the number andcharacteristics of actors who are able and willing to join public discussion and finally thegeneral attitude of a society towards science and innovation (friendly/averse).

29 Other demand creating factors such as a well developed health care systems with specialisedtransplantation centres and surgeons are beyond the scope of this study.


Supply side factors

All in all there is almost no research on xenotransplantation in Austria. The representative ofthe Austrian Transplantation Coordination Organization (ÖBIG-Transplant), a civil servantfrom the BMWV and a transplantation surgeon agreed, that to their knowledge there is noresearch on xenotransplantation in Austria. Only at the Veterinarian University in Vienna –here a research group is doing research on transgene pigs. Though Austrian transplantationsurgeons do not carry out research on xenotransplantation themselves, physicians at thethree Austrian university hospitals follow international research. The general absence ofresearch might be one important factor for the lack of public debate on xenotransplantationin Austria. Furthermore the small number of Austrian pharmaceutical companies working inthe field of biotechnology in general (cf. chapter 2) and on xenotransplantation in particular,might be also responsible for the non-existence of a public debate.

Demand side factors

The availability of a sufficient number of organs from human donors is probably the mostinfluential demand side factor which affects the intensity of public debate onxenotransplantation. A comparison of different European countries in 1998 shows, that thenumber of transplantations and thus the number of available organs differ greatly acrossEurope (cf. Table 28).

Table 28: Number of Transplantations of Selected Organs in Selected EuropeanCountries per Million Population (1998)

A D F GR(*) NL SP

Number of donors 19.8 13.4 16.9 5.7 13.1 31.5

Number of renal transplants from cadaver 40.4 25.0 30.8 8.7 25.3 49.8

Number of renal transplants from live donors 5.9 4.3 1.2 8.2 7.0 0.5

Heart transplants PMP 11.7 6.6 6.3 1.3 2.7 8.8

Source: ÖBIG-Transplant (2000): 38, (*) Organizatión National de Transplantes (1999)

Diagram 15 shows that Austria is second after Spain measured by the number of donors permillion inhabitants, and that Austrian surgeons perform transplantations more often thanmost of their colleagues in other European countries. Austrian surgeons are first in thenumber of heart transplantations and second in the number of renal transplantations fromcadaver as well as from live donors measured by transplantations per million population.These facts raise two questions: Why does Austria have such high number oftransplantations and, given these high numbers, is there still organ shortage?


Diagram 15: Number of Donors in Selected European Countries per MillionPopulation (1998)

31,5

19,816,9

13,4 13,1

5,7

SP A F D NL GR

Source: ÖBIG-Transplant (2000): 38, (*) Oranizatión National de Transplantes (1999)

A first but maybe too simple explanation for the high number of transplantations is theAustrian law, which regulates organ donation. The Federal Austrian Hospital Law (KAG § 62a), b) and c) permits to take organs or part of organs from deceased if the transplantationcan save another human’s life or can restore his/her health. The condition for explantation isbrain death. Furthermore the Austrian law applies the so called "opposition solution" (Wider-spruchslösung). This regulation assumes that the deceased agrees with organ donation aslong as he/she did not explicitly express his/her opposition against it, e.g. by entering his/hername into the so called "opposition register" (Widerspruchsregister) (cf. ÖBIG Transplantquoted from www.tpiweb.com/infobank/laneder/at/atmenu.htm). The Opposition Register is acentrally administered list, which can be retrieved by transplantation surgeons 24 hours aday to find out before explantation whether a deceased opposed organ donation. Austriantransplantation centres committed themselves to follow this procedure. Though theopposition solution seemingly solves the question of organ donation in a clear andtransplantation friendly way, the problem with the regulation is that only few Austrians knowabout it. Thus, by December 31st 1999 only 4.577 Austrians had entered their names into theregister (ÖBIG 1999: 60). Because of the information deficit and the subsequent low numberof entrances, the opposition solution suffers from some legitimacy problems. In any case, thenumber of entrances cannot be equated with a high acceptance of transplantation in Austria.

Despite the opposition solution, not all brain death patients become donors. A study from1995 estimated the number of potential donors in 1993 at 872, however the number ofdonors was only 214 (ÖBIG 1995: 19 and 7). Thus, in 1993 less than one quarter of allpossible organ donations were realised. Interviews with a transplantation surgeon and withrepresentatives from a self-help group showed, that the availability of transplants not onlydepends on the legal regulation of organ donation but also on several organisational,psychological and financial factors. Some of these factors are: (1) The priority organdonation is given in a hospital, i.e. the willingness of surgeons to explantate and to dedicatetheir and the nursing staffs' (often) scarce work capacity and equipment to a brain deathbody (and not to a living patient), given that financial income and medical prestige oftransplantation might be reaped by someone else. (2) The training of physicians intransplantation and related medical fields. (3) The willingness of doctors and nursing staff to


inform relatives of potential donors about organ donation and brain death and to encouragethem to agree with a donation, a discussion which is often psychologically burdensome forboth parts. (4) The quality of co-operation between hospitals, surgeons and nursing staffduring organ ex- and implantation. (5) The coverage of costs by health insurances along theentire chain of organ explantation, transport and implantation. (6) Despite the oppositionsolution, the willingness of the public to donate organs still affects the number of donations.According to the interviewed transplantation surgeon, physicians would refrain fromexplantation in cases of strong resistance from relatives, although this is not provided by law.Furthermore, surgeons would follow a general non-explantation-policy if they have thefeeling that transplantation is not backed by the local population.

Given these many factors which decrease the number of actual organ donations by nearlythree quarters of the potential, the opposition solution can hardly alone be responsible for thehigh number of transplantations. According to the interviewed surgeon other major factors isconstant information of physicians and nursing staff available, in particular of anaesthestistsduring their training at intensive care units.

Regardless of the high number of transplantations and the opposition solution, by the end of1998 994 people were waiting for transplantation (www.tpiweb.com/infobank/laneder/at/atmenu.htm). Among the patients waiting for heart or liver transplantation, every fifth is dying onthe waiting list (ÖBIG: o.J.).

In summary, despite the high number of transplantations and the transplantation friendlylegal regulation also in Austria, transplants from human donors are short. Although organshortage seems to be less massive than in other European countries, waiting lists exist andpatients are dying while waiting for suitable organs. Therefore, also in Austria, organshortage and the subsequent demand for xenotransplantation is used as the main argumentby the advocates of this approach.

Characteristics of public debate on controversial scientific issues

There are several characteristics which are relevant for the country-specific culture of publicdebate on science. One of them is the existence and arrangement of institutionaliseddiscursive forums for public debate of controversial scientific and technological issues. Suchforums might be Parliament, parliamentary or governmental advisory boards, or forums,which are particularly organised for this debate, e.g. consensus conferences. In Austrianeither the Parliament nor the Advisory Board on Transplantation at the AustrianTransplantation Co-ordination Organisation30 discussed xenotransplantation in theirsessions. So far, also no special public forum was set up to discuss xenotransplantationmore deeply. Only the Advisory Board on Biotechnology at the Federal Chancellerydiscussed "security questions of xenotransplantation in a general way" (BMFV 1999: 4).

30 The Advisory Board on Transplantation comprises of transplant surgeons and representatives fromprovinces and communities as financiers of hospitals, from statutory social and health insurance, theMinistry of Health, patient representatives as well as the transplantation organisation (Austro-transplant).


According to a civil servant in the BMFV, this was done only very briefly. No interviewedexpert knew of any Austrian forum where xenotransplantation is intensely debated.

The intensity of media coverage is another important characteristic of public debate onscience. According to a civil servant from the BMWV there is "certainly no controversy (onxenotransplantation) in the public sphere, because the issue does not really exist in Austrianmedia in the sense of an Austrian participation. Of course the issue is raised from time totime". A virologist interviewed thinks that Austrian media do not report on biotechnology withthe same intensity as German media do. Therefore, discussion on xenotransplantation mightbe less agitated in Austria than in other countries. A look at Austrian newspapers andmagazines shows that xenotransplantation is not very important measured by the number ofarticles:31 The quality newspaper which covers xenotransplantation the most is "DerStandard" (22 articles since October 1997), followed by "Salzburger Nachrichten" (11 articlesbetween May 1997 and March 2000). Another quality newspaper, "Die Presse" did not coverthe issue at all. From the daily tabloids the "Kurier" had three articles between October 1996and March 1999 whereas the Austrian newspaper with the most readers, the"Kronenzeitung" did not cover the issue. In summary, in the past three yearsxenotransplantation as an issue had only little coverage in Austrian quality papers and wasalmost non-existent in Austrian tabloids.

Another factor which cannot be studied more closely in this research is the attitude of thegeneral public towards science and innovation. A civil servant from the BMWV considersAustrians as a country not friendly towards science. This would also show in the low mediacoverage of science. This low priority might also be responsible for the lack of controversieson scientific issues.

The number and position of actors who are willing and able to join public discussion isanother characteristic of public debate on science. Who are the potential actors in anAustrian xenotransplantation controversy?

The potential actors can be divided in several groups: actors from the supply side, actorsfrom the demand side, policy actors, financiers, actors who act as spokespersons forspeechless actors such as the environment, animals, public health and public opinion.Important actors on the supply side are public and private research, working on geneticallymodified donor animals and pharmaceuticals which counteract rejection mechanisms as wellas transplantation surgeons and industry which produces immunosupressant drugs. On thedemand side there are self-help groups and patient advocates representing patients whowould benefit from xenotransplantation. Animal welfarists, environmental groups, virologistsand social scientists act as spokespersons for animal rights, the environment, public healthand the public opinion respectively. On the policy side there are ministries involved, whichare responsible for science-, health- and biotechnology policy. Furthermore there arestatutory and private health insurance companies who will have to bear the costs.

31 In our study we searched by internet in newspaper archives for articles with the keyword "xeno-transplantation".


So far, transplantation surgeons are the most prominent actors in the public discussion onxenotransplantation in Austria. In the small number of newspaper articles on xenotransplan-tation they are the kind of experts most often asked. In comparison, virologists appear lessoften in newspaper articles.

One of the most striking features of the present debate is the complete absence of animalwelfarists and environmentalists. This differs remarkably from their deep involvement in theGMO-food-debate. None of three interviewed animal welfarist groups and environmentorganisations is running a xenotransplantation campaign at present. A representative fromGreenpeace stated that her organisation would be, in principal, against xenotransplantation,however, does not have any detailed position. A representative of Global 2000 said that, sofar in her organisation, no co-ordinated opinion on xenontransplantation exists. The animalwelfarist group "Vier Pfoten" (four paws) sent on request a short standpoint paper. Onereason why environmentalist groups refrain from joining in the discussion may be their heavyinvolvement in the GMO-food-debate, which takes up much of their capacities. Also patientself-help groups are absent in the debate. However, according to the interviewedrepresentative of a patient self-help group and the transplantation surgeons, patients wouldimmediately accept xenotransplantation.

On the level of administrative authorities the BMWV is responsible for fundamental research.A representative of the ministry is member of the OECD working group "Human HealthRelated Biotechnologies". One of the issues of the working group is xenotransplantation.Thus the BMWV is informed about the international development on xenotransplantation,however, does not fund any related activities in Austria. The BMWV has responsibilities inbiotechnology, but not for xenotransplantation, which at present is not covered by the Genetechnology Act. However, because of the risk that viruses might be transferred from animalsto humans, it is considered within the Ministry whether xenotransplantation might be includedinto the Gene technology Act. These thoughts at civil servants level are still at a very earlystage. The BMAGS is responsible for health policy. According to a civil servant from theBMAGS the Federal Hospital Law (KAG: § 8 Abs. 2) and the Physician Law (Ärztegesetz §49 Abs. 1) also apply for xenotransplantation. These laws regulate the tasks of hospitals andphysicians. An important role within these regulations relates to "the state-of-the-art". Atpresent the state-of-the-art does not cover xenotransplatation.

According to a representative of ÖBIG-Transplant, no surveys exist on the public opinion inAustria about transplantation. However, interviews indicate vaguely that acceptance oftransplantation in Austria might be possibly higher than in other European countries. Firstly,there are historical reasons for this assumption. Already empress Maria Theresia ordered inthe 18th century that all patients who die in hospital must have a post-mortem. An interviewedvirologist thinks that this regulation led to a different attitude towards the dead body andorgan donation. Another indication towards a relatively high acceptance of transplantationcan be found in a private and not randomised investigation performed by a transplantationsurgeon. In his study he contacted ca. 350 spectators of a rural festivity. None of the peoplecontacted reacted negatively or hostile towards transplantation. Of these 350 people, ca. 70people also filled out a questionnaire. Despite the low number of respondents, this not-


randomised study gives some hints about the acceptance of transplantation in Austria: Ca.70% to 80% of these respondents stated that they would accept transplantation as atreatment and ca. 70% stated that they would donate organs.

In contrast to the vague indications towards the friendliness of the Austrian populationtowards transplantation, opinion polls show great scepticism of the Austrians towardsxenotransplantation. Diagram 16 illustrates that Austria, in comparison to several selectedEuropean nations, is the country with the smallest proportion of population consideringxenotransplantation as useful for society (32%). From the selected countries, Austria is theonly one with a (when narrow) absolute majority considering xenotransplantation as notuseful for society (51%).

Diagram 16: Responses to the Question of Usefulness of Xenotransplantation inSelected European Countries32

3241

47 51 53 56 5969

51

39 4246

3628 32

1716 1911

310

169

15

A IRL D NL UK GR F SP

Agree Disagree Don’t know

Source: Durant et al. 1998: 249 (own calculation)

Diagram 17: Responses to the Question of Risk of Xenotransplantation in SelectedEuropean Countries33

74 7063

57 55 53 5046

23 21 25 2433 28 29

36

48 12

2012

19 21 19

NL UK F IRL D SP GR A

Agree Disagree Don’t know


32 Question: Do you definitely agree, tend to agree, tend to disagree or definitely disagree that it isuseful for society to introduce human genes into animals to produce organs for human transplants,such as into pigs for human heart transplants?

33 Question: Do you definitely agree, tend to agree, tend to disagree or definitely disagree that it is riskyto introduce human genes into animals to produce organs for human transplants, such as into pigs forhuman heart transplants?


Interestingly enough, however, in contrast to this disapproval the proportion of Austrians whoconsider xenotransplantation as risky is smaller than in other European countries (43%, cf.Diagram 17).

Furthermore, the relative share of the Austrian population who consider xenotransplantationas morally acceptable is next to last in comparison (27%, cf. Diagram 18).

Diagram 18: Responses to the Question on Moral Acceptability ofXenotransplantation in Selected European Countries 34

47 45 39 34 33 28 27 2434

51 5144

55 60 57 53

19

4 1022

12 12 1724

SP NL F GR UK D A IRL

Agree Disagree Don't know


Finally, the relative share of the Austrian population who think that research inxenotransplantation should be encouraged in society is the smallest in internationalcomparison. Less than a quarter of respondents want society to encourage xenotransplan-tation and the majority of 56% disapproves such encouragement (cf. Diagram 19).

Diagram 19: Responses to the Question on Encouragement of Xenotransplantation inSelected European Countries 35

53

44 44 4135 32

28 2626

53

4437

51 5548

56

22

3

12

2214 13

2418

SP NL F GR UK D IRL A

Agree Disagree Dont'know


34 Question: Do you definitely agree, tend to agree, tend to disagree or definitely disagree that it ismorally acceptable to introduce human genes into animals to produce organs for human transplants,such as into pigs for human heart transplants?

35 Question: Do you definitely agree, tend to agree, tend to disagree or definitely disagree that societyshould be encouraged to introduce human genes into animals to produce organs for humantransplants, such as into pigs for human heart transplants?


The attitude of the Austrian population towards xenotransplantation can be summarized asrather negative. An absolute majority of the Austrian population considers xenotransplan-tation as not useful for society (51%), as morally unacceptable (57%) and as an approachwhich should not be encouraged in society (56%) respectively. Little less than half theAustrian population considers xenotransplantation as risky (46%), however, this share is thesmallest in comparison with selected European countries.

In summary, there is almost no public debate on xenotransplantation in Austria. So far therewas neither an intense political debate in the narrow sense in Parliament, nor was there anexpert debate in advisory bodies. Finally there was also little public debate in the media.Several reasons might be responsible for this lack of debate. Firstly, there is no acute reasonfor controversy since there is no public or private research in this area in Austria. Secondly,organ shortage might be less important in Austria than in other European countries. Thirdly,potential opponents of xenotransplantation did not form up so far. Environmentalists andanimal welfarists did not take up the issue. Fourthly, there are indications that Austrians areless interested in science and technology than other Europeans or US-Americans, whichmight show in the little media coverage on scientific issues in Austrian newspapers.

What are the positions of actors in a potential controversy?

The arguments for and against xenotransplantation used in the internationalxenotransplantation discussion (cf. e.g. Reiss et al.1998) can be divided into severalcategories. Firstly, there are medical chances and risks, which are either relevant for anindividual patient or for the population in general (public health). Furthermore there is the riskthat the research and use of xenotransplantation might diminish research efforts inalternative therapies. A second category relates to psychological risks for the individualpatient and a third category refers to ethical risks for the entire society. Finally there arefinancial risks for private or statutory health insurances, who will have to financexenotransplantation. Table 29 applies this systematic on the opportunities and risks ofxenotransplantation stated in Reiss et al. 1998, and provides an overview on the argumentsused in the international debate. This systematic will be used to analyse the position ofactors in a potential Austrian controversy on xenotransplantation.


Medical Risks

Medical Risks for the individual

Hyperacute rejection and semi- or subacute rejections are important medical risks for theindividual patient. In contrast to hyperacute rejection, however, semiacute rejection has notbeen solved so far (cf. TAB-Brief 1999). The transplantation surgeon interviewed explainedthe call for a mortatorium for clinical trials not as a step to reconsider the infection risk withanimal viruses but as a measure to protect patients from unacceptable treatment tocounteract semiacute rejection. He thinks that the problem of semiacute rejection will besolved by genetic modifications. According to the interviewed surgeon, xenotransplantationwould allow for earlier transplantation without having to bridge patients pharmaceutically untila suitable organ is available.

In contrast, the animal welfarist organisation "Vier Pfoten" is less optimistic and stresses thedanger of rejection. This risk would be already present in allografts and would be increasedin xenotransplantation. The necessary pharmaceuticals to suppress rejections would haveimmense side-effects. Another problem for the individual patient would be that the organismsof animals and humans would differ and be incompatible.

Medical Risks for the general population

The main risk for the general population is that diseases which, so far, only exist in animalsmight be passed on to humans. This would not only be a threat for the health of an individualpatient but would endanger the general population. Actors do have a different perception ofthis risk. Whereas on the one hand the transplantation surgeon, a virologist and therepresentative from the BMWV are optimistic that this danger, though it cannot be completelyruled out, is less critical than previously thought, on the other hand, virologists and animalwelfarists perceive it as a major threat.

In the opinion of the transplantation surgeon, the threat of transferring animal diseases tohumans does exist, but he estimates the chances as highly unlikely, comparable with thechances for epidemic measles. He reasons, that transplantation with porcine cardiac valvesdid not cause any viral infection from animal to humans. Also, a civil servant of the BMWVargues in the same line and refers to a Novartis study. In his opinion, the infection risk hasless priority today and is more unlikely than previously thought. A virologist, however,criticises this study, arguing that the xenografts analysed in this study were not geneticallymodified. He argues that modification of animals would also result in modified viruses, thus itwouldn't be sound to compare genetically modified xenografts with those not modified. In hisopinion, the study does not exclude the risk of virus infections from animals to humans.Nevertheless, he concludes, though a certain risk may exist, not to call for a moratorium butto start with xenotransplantation slowly and accompanied with adequate and reasonablesafety regulations.


In contrast, another virologist considers xenotransplantation as a risk for the generalpopulation (personal communication, Virusepidemiologische Information 3/1998) and alsoanimal welfarists emphasise the infection threat. The animal welfarist organisation "VierPfoten" thinks that this danger cannot be warded off by genetic screening, since it is onlypossible to analyse known viruses. Also Global 2000 states that viruses and bacteria whichtransfer animal diseases could attack humans (global news 1/98, Gobal 2000)

Potential Impact on alternative therapies

Also, according to the risk that xenotransplantation might hamper alternative approaches,different opinions exist. Whereas the virologist interviewed stresses the limits of alternativetherapies, animal welfare organisations emphasise their potentials. The virologist interviewedconsiders artificial organs as not yet technologically mature. He thinks that prevention isimportant but does not help in cases of genetic defects. Moreover he stresses the limits ofprevention policy: it is difficult to change peoples’ lifestyles in a more health-promoting anddisease-preventing direction. He also thinks that it might be possible to increase the numberof donors, however, he thinks that there will never be enough donors to settle the demand. Incontrast, the animal welfarist organisation "Vier Pfoten" propagates alternative approachessuch as improvement of the organisation of organ donation, research into artificial organs,biotechnology in medicine and prevention policy to prevent diseases which might be curedby transplantation (cardiovascular diseases, lung cancer, cirrhosis of the liver.

Psychological risks

Which psychological problems do transplantation patients have? According to the opinion ofa patient from a self-help group, representative patients would not have a problem to livewith a xenograft. In his experience, the desire for a better live without the pain and limitationsof dialyses and multi-medication are that strong that the origin of xenografts would not matterfor patients. Further, in his experience only a minority of patients does have psychologicalproblems with transplantation. Also the virologist and surgeon interviewed think that the vastmajority of patients have no problems with their transplants.

Ethical risks

Ethical risks of xenotransplantation raised in the interviews concern changes in the attitudetowards dying and death as well as questions of animal welfare. The question of justallocation of organs has so far not been raised in the Austrian discussion. Also the questionwhether xenotransplantation will change the society’s attitude towards dying and death islittle debated. A virologist e.g. sees no particular threat of xenotransplantation in this respectbecause he thinks, medicine has already entered the track of transplanting organs: "I do notthink that it will change fundamentally now. I think we already started this process, that we tryto change and delay natural processes. I do not think, that xenotransplantation will changevery much". In contrast the representative of Global 2000 considers it a disgusting mentalityto "repair people like machines".


Ethical questions concerning animal welfare can be divided into three categories: the right tokill animals for organ donation, the right to modify their genetic information and the questionof their appropriate keeping.

The right to kill animals for xenotransplantation is little discussed in Austria. Since it is noethical problem for most people to eat pork, the virologist and the surgeon consider it also asjustified to kill animals, in particular pigs, for organ donations. They think that thisargumentation will also be accepted by the public.

Also the question whether it is justified to change the genetic information of animals is littledebated. The virologist interviewed states that it would be a problem, if the modificationwould harm the animal, which in his opinion is not the case in xenotransplantation. Theanimal welfarist organisation "Vier Pfoten", however, opposes genetic manipulation ofanimals arguing that increased animal testing will be necessary and that new diseases mightdevelop which might be harmful for humans as well (Vier Pfoten 1999).

In comparison to other ethical problems, the question of appropriate keeping of animalsseems to be the most debated one. The interviewed patient self-help group representativethinks that the keeping of donor animals should be humane. They should live a good life untiltheir end. But the notion of good life and appropriate keeping is debated and open forinterpretation. The virologist interviewed thinks that though they do not have mud to dig in,the animals raised for xenotransplantation have spacious and clean shelters. He raises thequestion whether animals will miss any factors in their environment which they never knew ofin their life. The animal welfarist group "Vier Pfoten" however criticises the keeping of donoranimals as catastrophic: in order to keep the infection risks for humans as low as possiblethey would have to live in a germ free environment, they would never be at pasture andwould get no fodder appropriate for their species. These animals would be raised inlaboratories, which are not appropriate for their species (Vier Pfoten 1999).

Cost

The question of costs of xenotransplantation were not debated in the newspaper articlestudied. Since there is no xenotransplantation discussion in Austria at present, norepresentative of insurances was interviewed.

What could be the future development of the controversy?

Most interview partners agreed that also Austria will go through a xenotransplantation debatein the future. A representative from BMWV thinks that xenotransplantation will become anissue as soon as clinical studies will start in other countries. Then the discussion will start "inAustria, as always, after the event". Also the virologist can think of no reason why the topicshould not be debated in Austria with similar excitement as in other countries. Thetransplantation surgeon expects a fierce and "militant" controversy, comparable with theGMO-food debate, in which the advocates of xenotransplantation will meet stiff oppositionfrom an alliance of animal welfarists and environmentalists. He expects this controversy


when first clinical studies start. Concluding from the present discussion, the debate willpresumably deal mainly with the infection risk for the general population and with animalrights and less with other ethical questions or questions on equality in the health caresystem.

Conclusion

So far there was no controversy on xenotransplantation in Austria. At present, the debateseems to be in an undeveloped stage. Not only the general public but also most political andadministrative authorities seem to be relatively unaware of a potential controversy onxenotransplantation. Several reasons might be responsible for this: Since Austrian public andprivate research doesn't work in this field, there is no acute reason for debate. Austria has arelatively high number of organ donations, thus – despite waiting lists - organ shortage mightbe less urgent than in other European countries. Opponents of xenotransplantation seem tobe absorbed in the GMO-food-debate and did not start a discussion yet. Furthermore Austriadoes not have a big tradition of debating controversial scientific and technological issuespublicly: newspapers cover such issues not very intensely and there is almost no tradition ofinstitutionalized forums where these topics can be debated. The presumable actors of acontroversy can be divided into advocates (xenotransplantation researchers, transplantationsurgeons, patient representatives) and opponents (environmentalists, animal welfarists,some virologists). So far mainly the risk that animal diseases might spread over the generalpopulation is taken as a theme. Ethical, psychological and financial questions have almostnot been debated so far.

2.4 Prospects for the Sector

During the 80s, the Austrian funding organization (BMWF and BMWV cf. chapter 1.2.1)carried out a top-down biotechnology programme. This research programme ended in theearly 90s and was not continued. At present, national and local government start torediscover biotechnology as a topic of industrial and research policy. One indication for thegrowing awareness of authorities is the Biotechnology Impulse Programme, which waslaunched in summer 1999 by the BMWV and BMwA. Furthermore, the city of Viennapromotes biotechnology by additional subsidies and supporting activities.

The following section will raise some of the strengths and weaknesses of biopharmaceuticalR&D in Austria and of the socio-economic, cultural and political background it is embeddedin. This section is based on literature (cf. Rosian et al. 1998, Clement et al. 1998, Berg et al.1999), our surveys on the Austrian biotechnology industry and PSR36 as well as on

36 18 out of 23 responding research institutes active in bio-pharmaceuticals reported supporting andhampering factors for biotechnology in Austria. With only three institutes stating supporting factors,the hampering factors were clearly prevailing. Companies reported less often about hampering andsupporting factors: Only seven of 13 companies active in bio-pharmaceuticals reported their opinionabout supporting and hampering factors. In contrast to research institutes, however, a larger share ofrespondents also stated promoting factors.


interviews with the co-ordinator of the IPB (November 18th, 2000) and a civil servant from theCity of Vienna (November 25th, 2000).

Opportunities

Cluster. The strong points of Austrian biopharmaceutical R&D are a substantial universitypotential, a critical mass of hospitals and – though in international comparison only few –large and small companies. In particular the Vienna health-cluster has some "engines" which– although owned by foreign companies – are rooted in Vienna, and linked up to somedegree with the knowledge infrastructure and smaller firms (van den Berg et al. 1999: 259).Given the size and structure of its economy and the available research infrastructure thepotential for new biotechnology firms in Austria is estimated at least at 40 (Clement et al.1998: X). Also the representative from the IPB perceives the availability of a large potential offundamental research at the Vienna Biocenter, the Vienna General Hospital, the AgriculturalUniversity and the University of Veterinary Medicine as one supporting factor. The civilservant from the City of Vienna also stated the general qualities of the location of Vienna (i.e.soft factors, low corporate taxation in international comparison) as supporting factors.

Qualified personnel. PSR institutes (2 institutes) as well as firms (2) perceive the goodtraining of students and quality of employees respectively as supporting factors.

Increasing political support. The IPB co-ordinator, the municipal civil servant, one PSRinstitute and company respectively, perceive targeted political support in the year 1999,increasing political commitment and the fact that political actors are starting to increasefunding in biotechnology as supporting factors.

Other supporting factors are very dispersed and include the following points: initiatives,which promote university firm linkages (1 institute), co-operation with university institutes (1firm), co-operation with foreign companies and R&D-institutes (1 institute), fundingorganisations FFF and FWF (1 institute), good funding and funding organizations (1 firm),development of biotechnology clusters (1 firm), small structures (1 firm), short ways andawakening for biotechnology in Germany and other European countries (1 firm). Also theamount of venture capital available for biotechnology increased in the opinion of the BPB-co-ordinator to an extent, that it might no longer be a hampering factor.

Barriers

Patent behaviour. An obstacle, which is often mentioned in the literature is the patentbehavior of Austrian scientists. In this line of argument, it is established that Austrianscientists consider publications more important than the practical application of theirresearch. As a consequence, there are only very few patents taken out by scientists. Inaddition, civil servants (e.g. university and hospital employees) cannot hold any patent. Theirpatents accrue to the hospital owner or the federal government (van den Berg et al. 1999:256). Furthermore Austrian universities have no offices which would advise scientist inpatenting matters and there are no university funds available to finance patent costs. Others


argue that there is no substantial industry which would apply patents (Rosian et al. 1998:105).

Lack of entrepreneurial spirit. Another argument for the low number of startup firms in Austriawhich is frequently used in public and scientific debate is a lack of entrepreneurial spirit ofAustrian scientists and their "negative attitude towards risk taking" (van den Berg 1998: 256).Also Jörg (1995: 112) notices a "weakly developed entrepreneurial spirit" among Austriansand an "unfavorable socio-cultural environment". The IPB co-ordinator sees "the problem notin the financing of projects but to get good projects". Austrian research in her opinion, isextremely orientated towards fundamental science and not geared towards the market.Entrepreneurship, to start up one’s own business and patent one's invention, is alien toAustrian researchers. Austrian researcher are risk averse and many researchers have a life-time tenure at university.

Lack of funding. An additional obstacle for start-up firms is the lack of outside finances.Researchers criticise insufficient research funding. Public funding should be expanded andits mechanisms improved (Rosian et al. 1998: 105). Lack of finances is also the hamperingfactor most often mentioned in our survey by PSR researchers (15 institutes). This group offactors includes "lack of basic financing of PSR", "funding by the principle of 'equally for all'","low income" for researchers. Another point of funding, criticised by actors is exuberantBureaucracy (1 firm, IPB) and a "funding jungle" (1 firm). Also the municipal civil servantinterviewed states that the fragmentation of funding would be a problem.

Lack of venture capital. Another hampering factor is lack of venture capital. However, thispoint is discussed controversially. Whereas Rosian et al. (1998: 83, 106) establish a lack ofventure capital, van den Berg et al. (1999: 205) state that "the availability of venture capitalhas greatly increased in the last few years, with several public and private funds, so moneyshortage can no longer be blamed. Rather, the investment needed to start a biotech firm isnot that high, as no expensive equipment is needed". Nevertheless, three institutes and twofirms state a lack of venture capital as a hampering factor.

Lack of public acceptance. A large part of the Austrian population shows a hostile attitudetowards gene technology (cf. chapter 1.2). However public acceptance of biopharmaceuti-cals is different and more differentiated. As an indicator, scientists in hospitals report thattheir patients welcome the application of biotechnology in medicine. Lack of publicacceptance is also a factor mentioned very often by PSR (12 institutes). This line ofargument includes the following issues: "biotechnology has a negative connotation in publicdebate", "the public is hostile towards technology in general", "tendentious information by themedia and activists", "critical", "sceptical" and "hostile" attitude of the population,"unenlightened public". Lack of acceptance in the Austrian population is the hampering factormost often stated by firms (6). The short statements include: "negative media coverage","insular mentality", "public opinion hostile to science in general". Also the IPB co-ordinatorand the municipal civil servant perceive negative public opinion and mentality, technologyscepticism and the general climate towards biotechnology in the Austrian populationrespectively as a problem.


Lack of political support. Another argument in the realm of attitudes refers to politicians, whosaw biotechnology "too long (...) as a threat instead of a chance. This has certainly notcontributed to a favorable climate for start-ups in this field" (van den Berg et al.1999: 257).Two institutes report a lack of political support for, and even opposition to, biotechnology ingovernment. Lack of political commitment is the hampering factor stated second most oftenmentioned by firms ("with few exceptions lack of dedication", "reluctance to decide and toact", "debating whether something won't work instead of searching for solutions", "politiciansreacted years too late on promising biotechnologies", 4 firms).

Lack of industry policy. Another line of argument concerns industrial policy. Van den Berg etal. (1999: 257) criticise a lack of support for company foundation: "Although there are severalsupport organisations, what seems to be lacking is a dedicated structure for bio- or genetechnological start-ups, that need very specific professional legal, administrative andbusiness support. Also firm representatives criticise that the creation of new Austrian firms orbranch sites of multinational combines is supported only insufficiently" (Rosian et al. 1998:106).

Legal framework. Researchers in industry and PSR accept the Austrian gene technologylaw, which regulates the R&D in biotechnology. However, they condemn efforts to tighten thepresent law by introducing an additional hurdle of a environmental impact assessment. Inthis – as they conceive it – too lengthy an administrative procedure, it is examined whether aparticular action is tolerable for the environment (Rosian et al. 1998: 108; Clement et al.1998: 140).

Bureaucracy. Another hampering factor mentioned by respondents are infra-structural andbureaucratic problems at universities (7 institutes), which includes the "civil service law atuniversity", university structures, which hamper any "research, which is aiming at highperformance", lack of personnel and lab-space, too much red tape, and bureaucracy ingeneral.

Lack of critical mass and industrial back-up area. One institute stated the lack of a criticalmass of research as a problem and one firm considered "a lack of biotechnology firms andinnovation-friendly firms respectively" as a problem.


3 The Agro-Food Sector

Whenever the topic of gene technology is addressed in agriculture and food, it is mainly thedifferent fields of application in food processing that are focused on. The use of genetechnology may take place on different levels of food production and processing (cf.Culinar/Nohel et al. 1998: 3-4; Pfannhauser 1996: 6):

(1) Gene technological modification of plants and animals in primary agricultural production:Transgenic animals and GM plants as well as other products derived thereof. The use ofgene technology in plant cultivation should raise the resistance of plants (building upresistance to herbicides, insects, viruses; to unfavorable climatic conditions such as coldweather, drought), alter the nutritional quality of plants and plant products (changedcombination of plant ingredients and storage substance, elimination or introduction of(un)wanted ingredients or characteristics; addition of sweet flavor), raise the output, improvethe ability to be stored, delay the ripening process and shorten the cultivation time. The useof gene technology in animal breeding should raise the resistance of animals to infectiousdiseases, improve the utilization of fodder, accelerate growth and obtain different proportionsof meat or fat.

(2) Gene technological modification of microorganisms in food production: Foodstuffs thatwere produced by means of GM microorganisms, and GM microorganisms in processedfood respectively. About one fourth of all foodstuffs contain active or inactive microorganisms (sauerkraut, cheese, yogurt, sour milk, different kinds of ham, beer, wine, vinegar, etc.). Thetarget organisms for the use of gene technology primarily include yeasts, lactic acis bacteria,and mould fungi, which are used as starter, protective, or indicative cultures in the brewing orbaking industry, and in milk, meat, fruit, and vegetable production. GM yeasts may be usedin the baking and brewing industry. The use of gene technology should increase the size ofbread, alter the elasticity of dough, break down grain carbohydrates, shorten the storagetime, improve the decomposition of dextrin and enable the production of low-calorie beer.

(3) Gene technological production of food ingredients in food production: Using GMmicroorganisms for the fermentive production of auxiliary materials and additives such asenzymes, vitamins, sweeteners, flavors, thickeners, hormones. The use of microbiallyproduced enzymes plays an important part in the area of food production. This is also thearea where gene technology has progressed farthest throughout the world. Enzymes areused in almost all the different fields of food production (bread and pastries, beer, fruit juices,milk products, sugar, meat, etc.) The use of gene technology should raise the product yield,lower the costs, ensure a higher level of product purity, alter the stability of the product inhigh temperatures, decrease the proneness to infections (i.e. more process safety and betterhygiene). The production of additives by means of GM microorganisms is currently limited toamino acids, vitamins, and sweeteners.


Table 30: Technological State of Gene Technology in Food Production

TransgenicAnimals

- currently not ready for the market- meat and sausage production from transgenic animals are unlikely to be found

on the market- transgenic fish may be ready for the market within the next few years

GM Plants - currently not directly consumed as foodstuffs, only in form of processed foodingredients

- currently such ingredients are only found in a comparably small number offoodstuffs (there are, however, great differences between individual countries)

- currently these ingredients are almost exclusively made from GM soya, andsome of them also from GM maize

- the proportion of these ingredients derived from GM plants is clearly growing;

GM Micro-organisms

- hardly any market presence at this time- although some of these GM microorganisms are ready for the market;

Additives,Enzymes derivedfrom GMOs

- the gene technological optimization of microorganisms to raise the output in theproduction of amino-acids shows the greatest progress

- on a commercial level, however, this procedure plays a minor role- in the future, the proportion of enzymes in particular that are produced by means

of GM microorganisms will greatly increase- all new enzymes will be produced by means of GM microorganisms- traditionally produced enzymes will increasingly be replaced by enzymes derived

from GM microorganisms

Source: Culinar/Nohel et al. 1998 : 3-5, 70

Based on these fields of application, GM foodstuffs may be placed in three categories, asystem that also seems to be well suited for questions of labeling and identification(Pfannhauser 1996: 6; BMLF/Culinar et al. 1997: 57): foodstuffs and food ingredients, which(1) are themselves live GMOs, (2) contain live GMOs, (3) are products isolated or made fromGMOs.

Another important area for the use of gene technology in agriculture is the production andoptimization of renewable raw materials used in industrial production, which represent a newagricultural production niche (cf. Heberle-Bors 1996: 241): Renewable raw materials are rawmaterials whose decomposition products are returned to the cycle of raw materialproduction. This mainly applies to plants, the primary producers of organic matter. Firstexample – rape oil: The rape plant is genetically modified in such a way as to produce largeamounts of certain kinds of oil. Biosynthetic genes are isolated from exotic plants thatproduce fatty acids which may be interesting for industrial use (e.g. as a primary material forplastics) and transferred to a local oil plant, such as rape or sunflower. The use of transgenicrape oil can reduce the chemical expenditure that is necessary for converting plant oils.Second example – amylose-free plants: Starch plants that produce amylose-free starch,used as a raw material for the textile and paper industry, and as a paste or bonding agent forthe construction industry. Currently a costly technical and chemical procedure is needed toproduce it from normal starch in industrial potatoes. Transgenic starch plants provideamylose-free starch as a finished industrial raw material.



3.1.1 Public Funding Organisations

The main public organisations involved in funding biotechnology research are the BMWV, theFWF, the BMLF, BMwA (cf. Reiss 1999: 8, 18; detailed description cf. Chapter 1.3.1) and theFFF especially in the frame of the special programme "Food Initiative for Austria"(Lebensmittelinitiative Österreich).

In Austria, funding activities by the Provinces (Bundesländer) are not significant (cf. Reiss1999: 15). The analysis of public biotechnology research and development programmes inAustria showed that some Provinces co-finance special research programmes of the FWF(Austrian Science Fund) (cf. Reiss 1999: 15): The province of Styria, for instance, finances10% of the FWF programmes located in this region.

3.1.2 Research Organisations

A total of 11 university research institutes at 6 Austrian universities are currently conductingbiotechnology research in the agricultural and food sector. Besides that, one inter-universitary research institute and two non-university research institutes are working in thearea of biotechnology research in the agro-food sector. The main location for Universityresearch is Vienna with 7 University research institutes at 4 different Universities. One inter-university research institute and one non-university research institute are located close toVienna, in Lower Austria.

Table 31: Number and Location of Public Sector Research Institutes

Location No of universities No. of universityresearchinstitutes

No. of inter-university research

institutes

No. of non-university

research institutes

Vienna 4 7 - -

Graz 1 2 - -

Innsbruck 1 2 - -

Salzburg - - - 1

Lower Austria - - 1 1

Total 6 11 1 2

Sources: BKA/BMFV 1997; ÖGBT 1999; IHS-Survey 1999/2000, 1999

The major university research institutes working in the area of biotechnology in theagricultural and food sector can be found at the University of Agricultural Sciences(Universität für Bodenkultur in Wien – BOKU). A few research institutes working in theagricultural and food sector may also be found in other Universities. The Inter-university


Research Institute for Agro-Biotechnology – IFA-Tulln and the Non-university AustrianResearch Centre Seibersdorf – ARCS, Department Biotechnology mainly focus on the topicof agro-biotechnology which makes them the most important non-university researchinstitutes in the agro-food sector.

Diagram 20: Public Sector Research Institutes Conducting Biotechnology Researchin the Agro-Food Sector

University research institutes Inter-university researchinstitutes

Non-university researchinstitutes

Vienna â â â

University of TechnologyInstitute for BiochemicalTechnology and Microbiology

University of Agricultual Science ø Lower Austria

Institute for Applied MicrobiologyInstitute for Food TechnologyCenter of Applied Gentics ð

Interuniversitary ResearchInstitute for Agrobiotechnology

IFA-Tulln

Austrian Research CenterSeibersdorf - ARCS

Life Sciences

Institute for Chemistry ö

University of VeterinaryMedicine

Institute for Animal Breedingand Genetics

University of Vienna, ViennaBiocenter

Institute for Genetics andMicrobiology

Graz Salzburg

University of Technology

Institute for Biotechnolgoy

Austrian Academy ofSciences

Institute of MolecularBiology

Innsbruck

University of Innsbruck

Institute for analytical Chemistryand Radio-ChemistryInstitute for General andExperimental Pathology

Sources: BKA/BMFV 1997; ÖGBT 1999; IHS-Survey 1999/2000


The University of Agricultural Sciences in Vienna – BOKU has a number of institutesspecialising in the field of biotechnology and genetics. At this University, four researchinstitutes conduct biotechnological research in the agro-food sector. The most importantinstitute is the Institute of Applied Microbiology – IAM, which is dedicated entirely to the fieldof biotechnology focusing on basic research, biomedicine, environment, agriculture as wellas equipment. The IAM was established in 1945, and since then it has been largelycharacterized by collaborations with the Industry. Within the area of biotechnologicalresearch in agriculture, the principal focus is the cultivation of plants that are resistant to viraldiseases (e.g. apricot trees). In the autumn of 1999, a potential experimental release oftransgenic apricot and cherry trees that are resistant to the Shakra virus, took place withinthe context of a safety research project carried out by the IAM, led to a public debate (cf.Chapter 3.3.4). For quite a long period of time, however, the most important research focusof this institute has been on Pharmaceutics. Pragmatic considerations have suggested thatthe chances to get financial support and to realise individual projects would be better in thatarea – as it was pointed out by the institute (Source: face-to-face interview – head of theinstitute).

The Inter-universitary Research Institute for Agrobiotechnology (InteruniversitäresForschungsinstitut für Agrarbiotechnologie) IFA-Tulln was founded in 1994 by the Universityof Agriculture, the University of Veterinary Medicine and the University of Technology ofVienna as an independent research institute focusing on biotechnology in the field ofagriculture. The Department of Biotechnology in Plant Production and the Department ofAnimal Production are mainly involved in biotechnology research in the agro-food sector. In1996 the institute was asked by the Zuckerforschung Tulln GmbH to supervise theexperimental release of GM starch potatoes that was planned by this company. The releasewas not authorised (cf. Chapter 3.3.4). Although the IFA-Tulln surely has the know-how, theequipment, as well as the capacity that would be necessary to do research and work in thearea of gene technology – especially in the fields of cultivation of plants, environment, andanimal production –, it has decided to retire more and more from this area. Due to thegeneral restrictive climate in Austria towards the use of genetic engineering in agriculture it isnot possible to conduct any research or accept any contracts respectively. The IFA-Tullnconsiders itself to act as an interface between the economic sector and the flied of scienceand academic research. The institute derives an essential portion of the financial meansfrom projects and research contracts from the industrial or public sector. In order to obtain abetter position on the market, the IFA-Tulln Business Association (IFA-Tulln Betriebs-gesmbH) was founded in 1996 which was partly responsible for scientific projects as well asfor projects that emerge from their research activities (Source: face-to-face interview –managing director).

The Austrian Research Centre Seibersdorf – ARCS, Department for Biotechnology at theArea Life Sciences (Österreichisches Forschungszentrum Seibersdorf) made the firstapplication for the release of GMOs to the environment in Austria: A bio-safety projectinvolving GM potatoes, which was not released to the environment after all (cf. Chapter3.3.4). The Department of Biotechnology mainly focuses on agro-biotechnology, with woodyplants and economically useful plants in particular. Their research also includes the


resistance of plants to viruses, the safety of gene technology, micro-biological examinations(biotechnological and micro-biological testing methods). The ARCS is largely involved inapplied research and also acts as an interface between the Industry and Science. Becauseof the de-facto release moratorium in Austria (cf. Chapter 3.3.4) the opportunities tocollaborate with the Industry are very limited as compared to other countries. For that reasonthe research institute won't continue to do industrial research in the agricultural sector andtries again to focus more on basic research and on its competencies in the areas of geneticsafety research and transformation technology. They also try to engage in new research andproduct development in the biopharmaceutical sector, which is a new business area for theinstitute (Source: face-to-face interview – head of the institute)

It is rather striking that except for basic research, none of the research institutes exclusivelyconduct their biotechnological research in the agro-food sector. All of them are working inseveral different biotechnological research areas (cf. Table 3, Appendix 1).

The number of scientific employees is only known of 12 of the 14 university, inter-university,or non-university institutes. These 12 research organizations employ a total of 857.5researchers in the area of biotechnology, and only 121.5 of them are doing biotechnologicalresearch in the agricultural and food sector (cf. Table 4, Appendix 1).

The number of graduates is only known of five of the 11 university institutes working in theagro-food sector: Between 1994 and 1995 these five university institutes issued 21 Masterdegrees (first-university graduates) and 40 PhDs (second-university graduates) (cf. Table 5,Appendix 1).

3.1.3 Share of Total Biotechnology Research Funds Allocated 1994-1998

According to the analysis of public biotechnology R&D programmes in Austria (cf. Reiss1999), the areas of plant and animal biotechnology receive rather low financial fundingcompared to the other sectors. Between 1994 and 1998, altogether no more than 1.91% ofall public research funds were spent on animal and plant biotechnology (this is equivalent to0.97 MECU). The main public organizations engaged in funding research in plantbiotechnology were the BMLF, the BMWV and the FWF. Animal biotechnology is also mainlyfunded by the BMLF and the FWF (detailed description cf. Chapter 1.3.1).

Eight areas were defined for the analysis of public biotechnology R&D programmes inAustria (cf. Reiss 1999: 17): B1: Plant biotechnology, B2: Animal biotechnology, B3:Environmental biotechnology, B4: Industrial biotechnology – food, paper, etc., B5: Industrialbiotechnology – cell factory, B6: Human, veterinary biotechnology, B7: Basic biotechnology,B8: Non-technical areas. The areas B1 and B2 clearly belong to the agricultural sector. Sincethe area B4: industrial biotechnology also includes research in the food sector, one mayassume that the overall proportion of research funds for the Austrian agricultural and foodsector was higher than the aforesaid 1.91 % for plant and animal biotechnology, because asmuch as 36.72 % of the total research funds of public funding organizations were used forarea B4: industrial biotechnology (cf. Reiss 1999: 17).


In 1998 the FFF initiated the special initiative "Food Initiative Austria" ("LebensmittelinitiativeÖsterreich“), which supports the development and use of new technologies by foodcompanies. Apart from food production, the special promotion is also aimed at research andinnovation projects that are in any way connected with the topic of "foodstuffs" (e.g. theproduction of raw materials, auxiliary materials, and basic materials, new technologicaldevelopments in the area of production and packaging, components and systems, additives).From January 1st, 1998 to June 2000 a total of 183 projects were authorized in that context.The funds for these programmes amount to a total of 18.9 million EUROs (260 million ATS).21 of these projects belong to the area of biotechnology, which was funded with 3.6 millionEUROs (50 million ATS). The main priorities of these projects are in the areas of analytics(PCR) to ensure the quality of a product, fermentation technology, and plant cultivation(Source: written notification – FFF, July 6th, 2000).

3.1.4 Special Programmes for University/Industry Research Collaboration

Between 1994 and 1998 there has been no special programme for supporting university andindustry co-operations for bio- and gene technology research projects in the agricultural andfood sector.

3.1.5 National Involvement in Framework Programmes

The objectives of the FAIR-Programme were to promote research in the food and non-foodsectors of agriculture, horticulture, forestry, fisheries and aquaculture (cf. http://www.cordis.lu/fair/home.html). The programme covered the following thematic areas: 1) integratedproduction and processing chains, 2) scaling-up and processing methodologies, 3) genericscience and advanced technologies for nutritious foods, 4) agriculture, forestry and ruraldevelopment, 5) fisheries and aquaculture, 6) ethical, legal and social aspects – ELSA.According to the competent authority in Austria for the framework programmes of the EU, itis not possible to give an exact number of the FAIR-projects, that can be classed to the areaof bio- or gene technological research, and which have been coordinated by Austrianresearch organisations or in which Austrian research organisations have been activelyinvolved (Source: information by telephone – BIT, the competent authority in Austria forframework programmes of the EU).

Table 32: National Involvement in the 4th Framework Programme FAIR 1994-1998

FAIR Total of projects Austrian participation Austrian co-ordination

Programme proposed successful proposed successful proposed successful

4.076 882 405 107 29 20

Source: BIT, Bureau for International Research and Technology Cooperation, Info-Sheet



Joining the EU in 1994 has had a serious impact on the agrarian and food sector. Hardly anyother sector in the economy has been affected as deeply as this one by the EU entry. TheAustrian agricultural and food sector stands out for some specific characteristics:

- Austria's EU membership had a grave impact on the agricultural and food sector- Agriculture: small-scale, pioneer in bio-agriculture- Food production: small-scale, losses and structural changes- Food retailing: high level of concentration

The Austrian primary sector makes up 2.18% of the nominal GDP 1998 (Source: ÖSTAT).The agrarian structures in Austria may be described with three essential characteristics:Firstly, the Austrian agriculture stands out for its "microscopic" structure (mainly small familyenterprises). In 1997 about half of the farms were cultivating less than 10 hectares. Only1.3% of the farms owned more than 200 hectares of agricultural acreage (cf. Table 6,Appendix 1). With an average size of 15.4 hectares, the farms in Austria are clearly belowthe EU average (cf. Table 8, Appendix 1). Secondly, throughout Europe, Austria stands outas a pioneer in bio-agriculture: Austria has the highest number of organic farming enterprisesand the largest proportion of biologically cultivated areas (cf. Table 9, Appendix 1). Since1970 the number of organic farmers in Austria has continually increased. Since thebeginning of the Nineties organic farming has boomed: While in 1990 1 539 of the farms hadchanged to organic farming, their number was estimated to be as high as 20 100 in 1998 (cf.Table 10, Appendix 1). The extensive support of organic farming, which started in 1990 andwas increased step by step ever since, presented an important impulse for the greatincrease of organic farming enterprises in Austria37 (cf. Table 11, Appendix 1) (cf. BMLF1999: 209). Another reason for this positive development may be the better sales prospectsdue to the participation of large foodchains in the sale of organically grown products. Thismakes organically grown products accessible to a larger number of consumers, whereasuntil then, they were only available in special stores (cf. BMLF/Culinar et al. 1997: 35).Thirdly, the EU membership also greatly affected the agricultural structures in Austria. Theimplementation of a common agricultural policy – CAP, the elimination of frontier protectionand of a secured market value led to serious losses in the area of agriculture: Agriculturalend production (animal and plant production) was faced with losses of about one fourth(minus 24.8%) in 1994/95 (cf. BMLF/Culinar et al. 1997: 18). The trend to decrease thenumber of farms, which has already lasted for decades, continued (cf. Table 7, Appendix 1)(cf. BMLF/Culinar et al. 1997: 15).

37 1990 – "Extensivierungspilotprojekte" (pilot projects to extend organic farming): Subsidies for farmerswho want to switch to organic farming, provided that they are members of an authorised associationfor organic farming. 1991 – "Umstellungsförderung" (support for the change-over): Subsidies for allfarms that switch to organic farming. 1993 – "Biobauernzuschuß" (subsidies for organic farmers):permanent subsidies for all organic farms – regardless of whether they are in the process ofchanging-over or whether they have already switched to organic farming. 1995 – "österreichischesUmweltprogramm" – ÖPUL (Austrian Environmental Programme): along with joining the EU andtaking over the reformed common agricultural policy – CAP, the subsidies for organic farming werefurther extended (cf. BMLF 1999: 209).


There is very little literature and statistic material on the structure of the production of seed-grain in Austria. The total sales of the Austrian seed-grain economy for 1998 was of 94.4million EUROs (1.3 billion ATS) (cf. BMLF 1999: 72). According to the experts of the BMLF,the main part of the plants cultivated in Austria is imported from foreign countries and thenbred in Austria, while the share of seed-grain produced in Austria is very small. For example,only 4% of the maize cultivated in Austria is of Austrian provenance. 96% of the seed-grainof maize is originally bred by foreign, multinational seed production companies who employAustrian enterprises to multiply the seed-grain. There are about six or seven companies thatproduce seed-grain in Austria, only one of which produces original seed-grain. (Source:information by telephone – expert in seed economy of the BMLF).

The Austrian food-processing industry also operates on a relatively small scale with mainlysmall or medium-sized companies (cf. Table 12, Appendix 1). In addition to that, theproduction is primarily concentrated on the national market (BMLF/Culinar et al. 1997: 40).Not one of the 20 largest companies in the European food industry is Austrian (cf. Table 14and Table 15, Appendix 1). Compared to international production, the food production inAustria is estimated to be rather expensive, since large companies have a competitiveadvantage: 1. economies of scale, 2. automated production, 3. research and development,4. marketing, 5. businesses with large internationally active trade groups (cf. Weindlmaier1999: 42). After joining the EU in 1994, the rather favorable development of the Austrian foodsector was slowed down (cf. Table 13, Appendix 1). This radical change is due to theimplementation of the common EU policy and EU law and the opening-up of the Austrianmarket, which led to a considerable increase of international competition and a totally newpricing structure for agricultural products (cf. BMLF/Culinar et al. 1997: 39).

The Austrian food retailing industry is distinguished by a lasting concentration process andshows now a very high level of concentration: In 1998, the three largest food chains owned amarket share of 76.3 % and 60 % of the food stores (cf. Table 16 and Table 17, Appendix 1).The effects of this high concentration of the food retailing on the customers and suppliersdon't remain undisputed. On the one hand, this concentration process presents disadvan-tages for local supply (cf. BMLF/Culinar et al. 1997: 61), and on the other hand, the existingoligopolies may cause competition to become less effective, i.e. price advantages can't bepassed on to the customers (cf. Aiginger et al. 1999: 183). As to the business relationshipsbetween traders (food retailing industry) and suppliers (food processing industry), theseconcentration tendencies turned the market of supply into a market of demand, where thefood retailing industry dominates and defines the product line and has the so-called "marketpower" (cf. Aiginger et al. 1999).

3.2.1 Firm Characteristics

Biotechnology or gene technology respectively play a rather unimportant role in Austrianagriculture and food production. Only a handful of firms are working in this area in Austria. Itis especially remarkable that the group of biotechnology companies working in theagricultural and food sector in Austria is extremely heterogeneous. These companies havenothing in common, neither their range of products nor their fields of activity. They supply


different geographical markets and different target groups, they use different strategies for it,and their research and development patterns are also extremely heterogeneous. Theirhistory of origins doesn't have any common patterns either. There is no co-operationbetween the companies working in Austria – be it in the area of research and development orin view of their market penetration strategies. Co-operation with other companiespredominantly takes place on a European level. Every individual company thus represents aspecial case, which makes it more difficult to draw a combined picture of all the companiesinvolved in biotechnology in this sector.

The survey of the companies working in the agricultural and food sector was only able toidentify four active companies that actually employ any biotechnological and/or genetechnological methods (detailed description cf. Table 18, Appendix 1). Within the context ofthe biotechnology sectors that were examined in this study – biopharmaceuticals, agro-food,equipment and supplies –, only four of these companies are essentially working in the agro-food sector. One company is mainly working in the biopharmaceutical sector, but also has asmall production branch in the agricultural sector. Two of the companies are rather small withless than 50 employees, two of them are medium-sized with 100 employees in the first and500 in the second company, and one of them is a large company with more than 500employees. The biotechnology companies in the agro-food sector are mainly focusing on thetraditional area of biotechnology, i.e. bioprocessing:

Firm A is a small company with less than 20 employees and was established in 1989 as anindependent enterprise. Since 1994 the company has been part of a German feed industryconcern which is working in several European countries. The firm A is the "specialist forbiotechnology" within this group of companies. It may be seen as an example for a "smalldedicated biotechnology firm“, which develops an innovative biotechnological product andfinally uses that product in a larger group of companies to supply the market. The companyis working in the areas of product research, product development, and the development oftechnologies, i.e. starter cultures/performance enhancers and lactic acid bacteria, which areapplied in agriculture. Their products include silage inoculants and probiotics which are usedas animal food additives. 100 % of the turnover during the business year of 1998 came fromthe area of biotechnology.

Firm B has 40 employees and is a 100%-subsidiary to a large Austrian food and starchproducer. The firm B is responsible for the research and development programmes of theentire combine. The company was established in 1986. The firm B is also exclusively abiotechnology company, since 100% of the turnover within the business year of 1998 isallotted to the area of biotechnology. The company is working in the areas of productresearch, product development, and the development of technologies, i.e. sugar technologyand starch manufacturing and also offers services such as consulting and research (contractresearch, development for other companies). For experimental reasons, productionprocesses including the preparation, testing, and processing of new raw materials arecarried out on a small scale. The company itself does not use any methods involving genetechnology, but genetically modified new growing raw materials (e.g. GM potatoes for starchproduction) are biotechnologically prepared and processed (fermentation). The GM potatoes


are planted by a partner company on trial fields in Bavaria. Since releases are currentlyforbidden in Austria, the extensive technical and industrial production of starch from GMpotatoes is not possible in Austria either. In addition to that, the company also tries toimprove the process of fermentation. Currently the company does not have anybiotechnological products on the market, since the chances that the placement on themarket of starch products made from GM potatoes will be permitted are thought to be ratherslim. Due to the de-facto release moratorium (cf. Chapter 3.3.4) it is also impossible to plantGM potatoes and therefore the raw material can't be produced in Austria.

Firm C is the largest Austrian biotechnology company working in the agro-food sector38. Thecompany was established in 1948, and from the very beginning it has been engaged in theproduction of ethyl alcohol in fermentation. Whenever anybody in Austria talks about the longtradition of biotechnology this firm – together with another equally traditional company thatproduces biotechnology equipment – is always mentioned (see Chapter 4.3). The companyis involved in research and development, production and sale in the areas of biotechnology(fermentation), food technology, and chemistry. Currently the company has production sitesin Austria as well as in other countries in Europe and the rest of the world, and it is one of thelargest producers of citric acid and xanthan world-wide. Besides that, they also producegluconates and several other products that are made by means of fermentation, i.e.biocommodities. Citric acid is predominantly used in the beverage and food industry andxanthan serves as a thickener in food, pharmaceutics, and cosmetics. Although genetechnological methods for the production of citric acid have already been developed, thecompany does not use gene technology to produce citric acid since it can't be confirmed thatthe proportional increase of the output would reach an industrial level (Source: informationby telephone - head of the Professional Association of Chemical Industry of the EconomicChamber (Fachverband der chemischen Industrie der WKÖ) – gene technology expert of theFederal Environment Agency (Umweltbundesamt – UBA).

Firm D is a traditional Austrian biotechnology company which is mainly involved in thedevelopment and production of biopharmaceutical products (see Chapter 2.2). The companywas already established in 1946 as an independent enterprise and has over the years builtup several branches in Austria and Asia. The site in Austria has 2100 employees with 300people working in research and development. Since 1965, the company has been part of aninternational pharmaceutical group (headquarters in Switzerland), but the business locationin Austria is managed independently. More than 90% of the total turnover is allotted to theproduction of biopharmaceutical products. 100% of the research and development activitiesare in the area of pharmaceutics. The company is not involved in any research ordevelopment in the area of biotechnology in agriculture and food production. The productionof biotechnological products used in agriculture only represents a small proportion of theoverall production (less than 10% of the total turnover). This includes the production of arecombinant cow growth hormone, a veterinary medical product which causes cows toproduce more milk and the production of special fertilisers derived from biomass bacteria or

38 Unfortunately the company was not willing to give an interview. The information needed for thedescription of its activities was taken from: the company homepage, the European BiotechnologyDirectory '99; ÖGBT 1999; BKA/BMFV 1997).


fungi. Firm D produces the recombinant cow growth hormone in a large scale on behalf of acompany in the US which has also developed this product.

Three of the companies have biotechnological products on the market. Firm B does nothave any biotechnological products on the market, but it does offer services such asconsulting and research (contract research, development for other companies).

Two of the companies are known to have biotechnology patents pending – these beingmainly national and European patents. There is no data about the firm C, but it may beassumed that this company has applied for patents as well. The firm D is not known to haveany patents in the area of agriculture or food production, although they have been issuedpatents in the biopharmaceutical sector.

The commitment of these companies to research and development is very high: Four of thecompanies work in the area of product development, three of them in product research andthree in technology development. Two companies have products on trial. The biotechnologycompany D is not involved in any research or development in the area of agriculture andfood stuffs. This sector only presents some kind of "additional business".

3.2.2 Dominance of National, European, US or Rest of World Owned Firms

The companies in Austria which develop and/or produce biotechnological products or offerservices in the area of biotechnology respectively are mainly nationally owned enterprises.The firm A was established in 1989 as an independent enterprise, and since 1994 it hasbeen a subsidiary to a German feed industry company. The firm B is a 100% subsidiary to anAustrian sugar and starch manufacturer. The firm C has moved its headquarters toSwitzerland in the mean time, but is still known as an Austrian company with one of its mostimportant production, research, and development sites in Austria. The firm D was establishedas an independent enterprise, and since 1965 it has been a subsidiary to a multi-nationalpharmaceutical group. The company sees itself as Austrian based, that is working quiteindependently from the parent company.

3.2.3 Total Turnover of Sector and Source

The total turnover during the business year of 1998 is only known for three out of the fourcompanies. The proportion of the turnover of biological products is not available for all thecompanies either. Since the production of citric acid (which is mainly used in foodproduction) represents a large portion of the overall production in the firm C, it may beassumed that the largest portion of this company's turnover may be found in that same area.These are the reasons why the total sum of turnovers in the agro-food sector may only beseen as a rough estimate, which merely represents an approximation to the actual totalturnover. Any income from licence fees only play a minor part in Austria. There is no data inthis connection about the firm C.


3.2.4 Main Geographic Market

The main geographic market for biotechnological products is the US market, but also thedomestic, European and world market. The firm A predominantly supplies the domesticmarket. Due to the fact that it is part of a large German feed company group, firm A also hasaccess to the European market. The firm C is not allowed to place its product (therecombinant cow growth hormone) on the market in any of the EU member states, and that'swhy the US is the main market. The firm D has its own global distribution net and covers aconsiderable portion of the global market for citric acid and xanthan. The main geographicmarket for services they offer is the European market. The services are also offered on thedomestic market and in other countries.

3.2.5 Source of Technology

Three of the companies apply biotechnological methods and products that are based on theirown research and development. The firm D produces biotechnological goods in the agro-food sector on behalf of a company in the US.

3.2.6 Main Suppliers to the Sector

Since only a few companies are actually working in the bio-/gene technological area of theagro-food sector in Austria, there aren't many special suppliers in that area which are locatedor working in Austria. One important firm in the equipment and supplies sector is an Austrianbioprocess company, which is specialised in the production of biotechnological equipmentwhich is supplied throughout the world (cf. Chapter 4.3). According to this company, firm Cinstalls any new equipment on its own, without consulting a planning office (Source: face-to-face interview – Austrian bioprocess company). The in-house planning of biotechnologyequipment is quite common in biotechnology companies – this also applies to the firm D.

3.2.7 Collaborations with PSR

Of the firms in question, firms A and B state that they co-operate with research institutes inthe public sector, these being mostly domestic partner institutes. However, there are also co-operations with European and US partners from the public research sector. Unfortunately itis not known whether firm C collaborates with any research institutes in the public sectors.The firm D is not involved in any research or development in the area of biotechnology in theagro-food sector.

3.2.8 Collaborations with Other Firms

Two of the three companies in question also state that they co-operate with other firms in thearea of biotechnological research and development, which are mainly companies in otherEuropean countries. There is no data about the firm C in this connection either. The firm D is


not involved in any kind of research or development in the area of biotechnology in the agro-food sector.

3.2.9 Business Interest Non-Government Organisations (BINGOs)

(1) The Austrian Federal Economic Chamber (Wirtschaftskammer Österreich – WKÖ) co-ordinates and represents the supra-regional and national interests of Austrian commerce andindustry. In order to clarify their attitude towards gene technology, and as a reaction to theGene technology Popular Initiative (cf. Chapter 1.1.2 and Chapter 3.3.4), the Federal Sectionof Industry of the WKÖ presented a paper of their policy on gene technology in November1997 (cf. Bundessektion der Industrie der WKÖ 1997). This document points out that genetechnology will be a key technology in the future which, is already applied internationally inmany different research areas, as well as in the field of medicine, agriculture, basic industry,and therefore Austria must not shut itself off from this development. A ban or any kind oflimitations of the use of gene technology on a national level would have bad economicalconsequences and is thus unacceptable. One other reason for that would be the policy ofresearch-intensive companies which only invest in countries where the social circumstancesare thought to be favourable to technology. The politicians are asked to prevent any negativeeffects on an industrial site and to decrease the large number of legal restrictions tendencythat causes many industrial companies to move to other countries.

(2) The Federation of Austrian Industry ("Vereinigung der Österreichischen Industrie" or"Industriellenvereinigung" – IV): Die IV is a non-governmental institution that represents theinterests of the Austrian Industry. Membership is not obligatory. On the occasion of the GeneTechnology Popular Initiative, the IV also presented a position paper on the topic of genetechnology (Österreichische Industriellenvereinigung 1997): This paper points out that genetechnology has been established world-wide as a new future technology, which is alreadyapplied in many areas of research and industrial production. The opportunities of genetechnologies need to be recognised, but any possible negative effects of its use should alsobe taken into consideration. The IV rejects the general prohibition of the use of genetechnology and warns of so-called compulsory measures that could lead to grave negativeeffects on Austria as a research and industrial location.

(3) Forum Biotechnology: The Forum Biotechnology which was founded in April 1998 inresponse to the public controversies in connection with the Gene technology PopularInitiative, is an initiative of several companies from the food and seed sector which is locatedwithin the Federation of Austrian Industry. It consists of multi-national seed combines such asAgrEvo, Monsanto, Novartis, Pioneer and the Professional Association of the Food andLuxury Food Industry of the WKÖ. The membership of large food producers such as Nestlé,Kraft-Jacobs-Suchard, Knorr, and Unilever in the Professional Association of the Food andLuxury Food Industry also ensures their regular representation in the Forum. The ForumBiotechnology tries to increase the understanding and acceptance of the use of bio- andgene technology in the areas of agriculture and food production by means of extensive andunbiased information and a dialogue with all who are interested in this topic. A PR agency isin charge of lobbying and public relations, although the Forum does not pursue an active PR


policy. The preferred strategy is to establish a dialogue by talking directly to decision-makersand other important actors and by sending out press reports in response to the differentstates of development within the debate on gene technology (Source: face-to-face interviewwith PR agency in charge).


3.3.1 Market Size and Specific Characteristics

Up until now, no deliberate release of GMOs has taken place in Austria. Between 1986 and1999, a scant 1500 applications for the deliberate release for GMOs were made throughoutthe EU (cf. Table 19, Appendix 1). The official EU statistics on deliberate releases of GMOsstates that Austria has made three applications. Altogether, five applications were made inAustria, two of them were refused and three of them were withdrawn again due to publicpressure39 (cf. Chapter 3.3.4). Currently there has not yet been any notification of plantvariety testing in Austria for a plant seed variety with a GMO construct, whereas a largenumber of new varieties with a GMO construct are currently tested in other Europeancountries (Source: information by telephone – BLF, the competent authority for plant varietytesting and registration). Whenever a variety test is positive and a GM-plant variety has anEU-wide plant variety registration, it may be imported and cultivated in every EU memberstate. However, none of the registered GM seed varieties has yet been planted on Austrianagricultural land – which is partly due to the heated public debate on the release of GMOs inAustria (cf. Chapter 3.3.4). Although organic farming plays a comparatively important part inAustria, more than 90 % of the agricultural land is still cultivated with conventionalagricultural methods, and more than 90 % of the agricultural holdings are conventionalfarmers (cf. Chapter 3.2). It is not clear how large the demand for GMO seed varieties reallyis among conventional farmers, who may hope to obtain a certain competitive advantage orto limit the need for plant-protective agents by the use of GM seed. To promote organicfarming products, the Association of Organic Farmers in Austria "Ernte für das Leben" hasdeveloped a concept that should ensure agricultural production without any gene technologywhatsoever40 (cf. Ernte für das Leben/Arge Biolandbau 1998).

Up until now, there are no registered foodstuffs, food ingredients or food additives containingor consisting of GMOs in the Austrian food sector (cf. Culinar/Nohel et al. 1998: 53).However, right now there are a small number of food products on the Austrian market whichcontain or consist of GMOs, like GM maize or GM soya. In the course of an investigation,

39 Three applications for 1996 were passed on to the EU commission. However, the applications for1997 and 1998 were withdrawn before they could have been passed on to the commission andtherefore don't appear in EU statistics.

40 The label "free of gene technology" may only be used in organic farming if the following fourrequirements are met: no GMOs and genetically modified micro-organisms, no genetically engineeredadditives and auxiliary materials, no genetically modified working materials (no genetically modifiedfeed, no genetically modified organic fertilisers, no genetically modified seeds). (cf. Ernte für dasLeben/ARGE-Biolandbau 1998)


which was conducted by the Federal Institution for Food Examination and Research(Bundesanstalt für Lebensmitteluntersuchung und -forschung) on behalf of the BKA/BMFV,food controls with a focus on gene technology have been carried out since autumn of 1998.According to the latest state of investigations, 466 food samples that were already suspectedto contain GM maize or GM soya were analyzed. 49 of these "suspected" food samplescontained GM ingredients, even though they were not appropriately labeled (cf. APA25130.07.99) GM food ingredients were mainly found in the following product groups: liquidfoods, special diet foods, farinaceous foods, baked goods, soya drinks, spring rolls, breadedchicken, and chips (Culinar 1999: 34). In these cases, the products were mostly importedand not produced in Austria. But, it may happen that Austrian food processing companiesuse enzymes that were made from GM- microorganisms (cf. BMLF/Culinar et al. 1997: 57).The methods that are used to examine foodstuffs are not able to detect enzymes which weremade from genetically modified microorganisms. According to a Dutch enzyme producerthere are currently three enzymes made from GMOs that are exported to Austria: One(maturex) is used in breweries and two of them (maltogenase and termamyl) are not used infood processing but are used in the starch industry (cf. Culinar/Nohel et al. 1998: 67).

The feeding stuff production seems to be the largest client for and manufacturer of GMOsand GMO-products respectively in the agricultural and food sector. It is thus the link in theAustrian food production chain with the highest proportion of products that consist of orcontain GMOs. Since there hasn't been any official and extensive investigation for theidentification of GMO-products in fodder, and since the labeling of such products in notobligatory, there is no clear data available on this matter. That's why we had to rely on expertestimations: Soya meal can be found in almost all kinds of protein fodder, which amounts toabout 50% of all the mixed feeding stuff. Several analyses with regard to GMO identificationhave already been carried out. They showed that about 80% of the analyzed mixed feedingstuff contained soya meal made from GM soya (Source: information by telephone – BLF, thecompetent authority for feeding stuff control).

The Austrian food retailing industry shows a very high level of concentration and – asmentioned above – has the so called "market power" in the food sector (cf. Chapter 3.2). Thetwo largest food retailing companies – with a market share of von 60% (1998) – each havetheir own line of organically grown products. In the spring of 1997, the food retailing industrywent all out for a positive labeling of products that are guaranteed to be free of genetechnology, and together with several food producers and environmental organizations theyfounded the "Arbeitsgemeinschaft für Gentechnik-frei erzeugte Lebensmittel" ("Associationfor food stuffs made without gene technology") (cf. Chapter 3.2.9 and Chapter 3.3.4).

In 1998, several food chains (ADEG, Billa, Spar) and food producers (Kärntnermilch,Perlinger Naturprodukte, Toni’s Freilandeier, etc.), environmental organisations (Greenpeaceand Global 2000) and the Organic Farmers Association "Ernte für das Leben" establishedthe "Arbeitsgemeinschaft für Gentechnikfrei erzeugte Lebensmittel (Association for foodstuffs made without gene technology). The attempt was to establish a quality seal for foodthat is guaranteed to be free of gene technology. The purpose of this unique co-operationbetween the economy and environmental organisations was the mutual development of


quality standards for a positive labelling of food that is free of gene technology, as well as thecreation of specific conditions for the production and placing on the market of genetechnology-free products. Up to this point, however, only a very small amount of food stuffsavailable are labelled that way. Compared to the food stuffs with positive labelling there is avast amount of food stuffs that are not labelled. The significance of this label is still onlymarginal (cf. ARGE Gentechnik frei 1998).

3.3.2 Regulation Policy

(cf. Chapter 1.4.1)

3.3.3 Public Interest Non-Government Organisations (PINGOs)

In connection with the applications for the deliberate release of GMOs in Austria, the twoNGOs for environmental protection, Global 2000 and Greenpeace play a very active part. Incollaboration with the Austrian media they mobilised the Austrian population against therelease of GMOs in Austria (cf. Chapter 3.3.4). Further organisations, which were activelyinvolved in the protests against the release of GMOs, were the UmweltdachverbandÖsterreichische Gesellschaft für Natur- und Umweltschutz ÖGNU (Office for the Co-ordination of Environmental Affairs, Austrian Society for Nature and EnvironmentalProtection) and the Umweltberatung (Consultation Office for Environmental Affairs) (cf.(Martinsen 1997: 223).

Some other important PINGOs include the initiators of the popular initiative on genetechnology: "ARGE Schöpfungsverantwortung" (catholic environmental project), Österreichi-sche Bergbauernvereinigung (Austrian Association of highland farmers), Tierschutzverein"Vier Pfoten" (Austrian Society for Prevention of Cruelty to Animals "Four Paws"), "Ökobüro"(Office for the co-ordination fo Austrian environmental organisations), Forum österreichischerWissenschafterInnen für Umweltschutz (Forum of Austrian Scientists for environmentalprotection) (cf. Langthaler/Nohel 1998).

The main argument of criticism of the relevant PINGOs involved in this issue is the rejectionof gene technology applications in agriculture and food processing. The PINGOs emphazisethat they explicitly support activities in bio- and gene technological basic research as well asapplications of biotechnology in human medicine (for more details cf. Chapter 3.3.4).

3.3.4 Case Study of Controversy: GM Crops

In 1996, the first release applications for GMOs were made, which gave rise to an extremelyserious controversial public debate on the use of gene technology in Austria. In 1997 thiscontroversy reached its height with the so called Gene technology – Popular Initiative. Thepopular initiative was directed at gene technology in connection with food production, therelease of transgenic organisms, and taking out patents for living beings. The popular


initiative was the second most successful initiative in Austrian history: 1 225 790 Austrianssigned it (21.23 % of the people eligible to vote) (cf. Chapter 1.1.2).

While the risks and dangers of gene technology have already been discussed for years inother countries, on an international level the public discourse in Austria started rather late,i.e. only a year after legal regulations had been implemented (Gene technology Act –Gentechnikgesetz – GTG, BGBl. Nr. 510/1994, enforced in 1995). The year 1995 may becalled "the calm before the storm" (cf. Grabner/Torgersen 1998: 15): there were no publiccontroversies, but there were also no releases of GMOs either, which could have provokedconflicts like they did in other countries.

Only in 1996, when the first release applications for GMOs were handed in, was the topic ofgene technology first addressed in public. This controversy was known by both its highlyemotional public debate as well as by the fact that the media played an important part inscandalising the use of gene technology in agriculture and in the production of food stuffs.The chronological description of this controversy, the actors who are involved, as well astheir lines of argumentation are based on politico-scientific studies which extensivelydocument and analyse the process of this public controversy about the use of genetechnology. The most important sources are the politico-scientific analyses by (Grabner1999; Grabner/Torgersen 1998; Wagner et al. 1998 and Martinsen 1997). Further sourcesthat were used are mentioned separately in the text.

For a better understanding of the dynamics of this controversy about the first releaseapplications for GMOs, a short description of the notification procedure for deliberatereleases of GMOs in accordance with the Austrian Gene technology Act – GTG shall bepresented: According to the Austrian Gene technology Act the responsible authority has todecide on a release application within a period of 90 days (§ 40 GTG). This decision isbased on an expert opinion by the scientific committee of the Advisory Board on Genetechnology and on a public hearings (§ 39 (3) GTG). The release application has to be madeavailable to the public and the documents also need to be publicly accessible (§ 43 (1)GTG). Anybody who has reasonable objections to the release application has to submitthese in writing (§ 43 (1) GTG). The public hearing has to include: the members of theresponsible scientific committee, the notifier as well as everybody who has raised a writtenobjection to the release application (§ 43 (2) GTG). The Ministry of Environment, Youth, andFamily Affairs has to be informed and invited to take part in the hearing (§ 39 (5) GTG).

January-March 1996: Public debate on the 1st GMO release application – beginning of thepublic debate on gene technology:

Applicant: Austrian Research Center Seibersdorf

GMO: Bio-safety research project: GM potato plants with Erwinia resistance. Resistance tobacteria of a GM potato which was implanted with genes from the Giant Silk Moththat are known to delay decay (Erwinia-foulness):


The relevant authority for general affairs of genetic engineering (in 1996: Federal Ministry ofHealth, Sports, and Consumer Protection – BMGSK)41 tried to make sure that the firstrelease application in Austria was a bio-safety research project carried out by a researchinstitution. With this project, the Ministry of Health tried to avoid that the first deliberaterelease of GMOs in Austria would be that of herbicide-resistant plants from commercialapplicants. Because of the experiences that had been made in Germany, they were worriedthat a release application handed in by a company would cause more public attention.

The first public hearing on an Austria release application took place in March 1996. Alreadysince the first notification of the public there have been protests from many different sides.The public hearing itself also gave rise to far-reaching protests by the Green Party and byenvironmental organisations.

Lines of argumentation of gene technology critics:

Agriculture partly massive criticism of the use of gene technology methods in agriculture; basicargumentation: a relatively large number of organic farmers and a large proportion oforganic agriculture in Austria as compared to other countries within the EU.

ARGEBiolandbau42

Austria should be declared a "gene technology-free" zone

BMLF also sceptical position

The Green Party Points of criticism: 1) the involvement of the Ministry of Health who ordered thisrelease. 2) inadequate basic conditions for making the documents available to thepublic (unclear about the execution, since there was no executive order yet). Theresponsible authority was accused of "mystery-mongering". 3) The support of theresearch activity under the label of "safety research" as a means to raise theacceptance of the use of gene technology in agriculture.

Environmentaloranizations43

followed the argumentation of the Green Party

Global 2000 mobilised the population by means of pre-written protest forms (7000 objections werefiled with the responsible ministry at that time).

Expert opinion by the scientific committee for deliberate releases of GMOs of the AdvisoryBoard on Gene technology (cf. BKA/BMFV 1999: 12): The committee concluded that the trialrelease does not lead to any negative effects on human health and the environment, as long

41 In the period between 1995 and 1997, the Federal Ministry of Health, Sports and ConsumerProtection (BMGSK) was the relevant authority for affairs of the GTG (§ 100). In 1997, the affairs ofconsumer protection and the GTG moved to the competence of the Federal Chancellery/FederalMinister of Women's Affairs and Consumer Protection (BKA/BMFK or BMFV). The Federal Ministry ofScience and Research (BMWF) and after 1997 the Federal Ministry of Science and Traffic (BMWV) isresponsible for operations using GMOs in contained systems and releases of GMOs carried out byuniversities and Federal research institutions (§ 100 GTG).

42 Association for Organic Farming.43 Global 2000, Environmental Parent Organisation (Umweltdachverband ÖGNU), Ecology Institute

(Ökologieinstitut), Association for Environmental Protection (Naturschutzverbund), Chamber ofLabour (Arbeiterkammer), and other environmental organisations.


as the specific requirements are met (extensive monitoring programme, additional scientificresearch of the effects of modified genetic constructions of the ground flora).

March 1996: Public debate on the 2nd GMO release application – very little public attention:

Applicant: Zuckerforschung Tulln GmbH in collaboration with IFA-Tulln

GMO: GM potato plants for the production of a standardized Amylopectin starch. GMstarch potatoes with a modified starch structure (decreased amylose concentration)to be used as an industrial resource (strictly not for the food market) and wasannounced under the heading of “renewable resources”.

Even the critics thought that this trial release was economically harmless and therefore noserious resistance towards the project was expected.

Expert opinion of the scientific release committee of the Gene technology Commission (cf.BKA/BMFV 1999: 13): The committee concluded that the trial release does not lead to anynegative effects on human health and the environment, as long as some additionalrequirements are met (supervision of the trial, identification of the trial field).

April 1996: Public debate on the 3rd GMO release application – large public and mediainterest in the topic of gene technology:

Applicant: Engineering Office T.B. Agrartechnik (Agrarian Technology) in Bad Vöslau on behalfof AgrEvo

GMO: GM herbizide-resistant maize that contains the gene of a ground bacterium whichprotects the maize from a total herbizide by decomposing this substance

From the very beginning, this release application caused a lot of public and media interest aswell as a lot of resistance. Politico-scientific analysis stated that this application by theAgrEvo Company represented the actual beginning of the political controversy about thetopic of releases in Austria.


Agriculture serious resistance: argumentation: "double ecological danger": the question israised whether agro-industrial development makes sense, the use of herbicides onthe one hand, and the release of crops and other useful plants which are resistant toherbicides on the other hand.

BMLF massive doubts; announced that they would submit their objections to theresponsible Ministry; criticised the fact that the location of the trial areas in theaffected rural communes were kept secret

Green Partyenvironmentalorganisations

raised objections


Environmentalorganisationsespecially Global2000

mobilised the public and as a result about 30.000 written complaints about this trialrelease were filed with the responsible Ministry

BMUJF massive doubts

Media The local issue of the "Neue Kronen Zeitung" (tabloid newspaper) supported theenvironmental organisations in collecting signatures

Affected ruralcommunes

criticism, sometimes even vehement resistance: they were afraid that there wouldbe reputations in the matter of ecological farming

level of theregional province

"genetic maize" was declared to be "highly unnecessary"

The responsible Minister did not offer any statements in this public debate. She said that shewanted to wait for the expert opinion of the responsible committee of the Gene technologyCommission. This was criticised by gene technology opponents. This question was not ascientific decision but it was necessary to set a political course for Austrian agriculture.

April 1996: Failure of the 3rd application – environmental organisations and the tabloidsmobilised the population: The application was withdrawn because of the strong publicpressure. The company wanted to anticipate a negative decision by the responsible Ministry,since they did not want to take the risk of setting a precedent within the EU. The withdrawalof the release application was also seen as being a result of the successful co-operationbetween environmental organisations and the tabloids to mobilise the population. Since therelease application was withdrawn before the public hearing had started, the application wasnot examined by the responsible scientific committee.

Mai 1996: Failure of the 2nd application – a lot of emotions about the topic of genetechnology are created by scandalising the "illegal" releases – gene technology becomes apublic and internal political topic: Since the responsible institutions had given a verbalsecurity clearance to the Zuckerforschung Tulln GmbH, since the signing seemed to be onlya question of time, and since the right time for sowing should not be missed, the potatoeswere planted "in good faith" without a written release notice at the end of April.Environmental organisations informed the media about this "illegal" release and Global 2000activists secured the affected area. The mayor of the affected village was outraged since hehad not been informed of this release and he also joined the protests of some farmers. Theresponsible Ministry laid an information against the company. The trial release had to bebroken off and the responsible Ministry demanded that the potatoes were dug out again. Theresponsible Ministry was also partly responsible for this "illegal" release, since it missed thedesignated deadline of 90 days for the official decision due to the massive public rejection ofgene technology. A protest entered by the applicant was accepted by the HigherAdministrative Court with the argument that the proceedings had already reached a stagewhere a positive release notice could be expected.

This so called "illegal" release was used by environmental organisations, by the oppositionparties, and by the media to intensify the discussion of the general use of gene technology,


especially in agriculture and in the production of foodstuffs. This lead to a generalscandalisation of GMO releases, and the topic of gene technology became a preferred topicin the media. Meanwhile the public had also started to believe that gene technology in theareas of agriculture and food production is "dangerous".

May 1996: A release moratorium is announced and then withdrawn again: After thescandalisation of the so called "illegal" release, the Ministry of Health imposed a releasemoratorium. The press called the Minister's announcement of the moratorium an "over-reaction". The Federal Chancellor in turn corrected this announcement. The Minister ofAgriculture and the Minister of Environment also revised their negative attitudes, which theyhad assumed at the beginning of this controversy about the release applications. Theystated that gene technology should not be banned from Austria too hastily.

Mai 1996: Failure of the 1st application – because of the announced release moratorium: Theannouncement of the moratorium led to the fact that the release application by the AustrianResearch Centre Seibersdorf had to be rejected as well. The responsible Ministry was facedwith a paradox situation, because in the end, even though the Ministry of Health was one ofthe authorities who initiated this bio-safety research project, it prevented the release. Theresearch institute and the two other parties who had ordered the release agreed to continueand conclude the safety research project in a contained system instead of on the trial field.

Early summer of 1996: Gene technology and foodstuffs become the main points ofdiscussion: Gene technology is still a public and internal political topic. The discussion nowfocuses on the use of gene technology in the area of food stuffs and the labelling ofgenetically modified products or food. Compared to previous international discussions aboutthe release of GMOs, Austria has defined a new focal point: Besides the ecological dangersof GMO releases, the sense and purpose of genetic manipulations in the area of foodproduction is primarily discussed. In connection with questions concerning the protection andthe freedom of choice of consumers, the labelling of genetically modified food was especiallyfocused on.

August 1996: Official start of the popular initiative on gene technology: As a result of theheated public and internal political debates on the use of gene technology in the areas ofagriculture and food production, a group of environmental organisations initiated a popularinitiative on the topic of gene technology.

Autumn of 1996: Debates on the labelling and the import ban on GM soya and GM maize:The Novel Food Regulation (VO 258/97) was discussed on an EU level in the autumn of1996 and then passed at the end of 1996.44 In compliance with the countries who wereopposed to gene technology, the labelling regulations turned out to be more extensive thanthey were first intended: foodstuffs and food ingredients containing or consisting of GMOshave to be labelled if current analytical methods are able to distinguish them fromconventional products. However, this did not apply to GM-maize and GM-soya which had

44 For detailed information about procedures and actors relevant for the controversy about the the NovelFood Regulation see Rücker 1999: especially 137-248.


already been admitted for the placing on the market before the Novel Food Regulation waspassed. The import of GM-maize and GM-soya was controversial and led to a lot of protestsin Austria as well as in other EU member states.

February 1997: Prohibition of the placement on the market of genetically modified maize byCiba-Geigy (Novartis): The EU member states Austria, Luxembourg, and Italy prohibited theimport of Bt-maize of Ciba-Geigy (VO No. 45/1997, BMGSK). The import ban presented aviolation of EU law, since the scientific findings that the Austrian government relied on werehardly convincing in Brussels. The responsible Minister in turn protested by stating thatAustria would take the risk to be sued before the European Court of Justice, which wasextensively discussed in the media.

Spring of 1997: Public debate and failure of the 4 th GMO release application:

Applicant: Zuckerforschung Tulln GesmbH

GMO: renewed application for the release of the transgenic starch potato

The Zuckerforschung Tulln handed in an application for the release of genetically modifiedpotatoes. The application, however, was withdrawn again due to severe protests. After thatthe Zuckerforschung Tulln has moved its experimental releases involving amylose-freestarch potatoes to the neighbouring German state of Bavaria.

Spring of 1997: Request to abandon experimental releases: The responsible FederalMinister sent a written request to the companies in question to stop experimental releases inAustria as long as the public debate is not settled.

ðGene- technology critics:

mainly environmental organisations

óFederal Minister

ïGene technology supporters:

Industry and research

Accusation of the Federal MinisterLetter to thecompanies

Accusation of the Federal Minister

This measure is not binding enough.Demand for a legal release moratorium.

Request torelinquish the

releases

The Federal Minister is not impartial to trial releases and is therefore trying to

avoid them.

Autumn of 1996 to Spring of 1997: Campaign for the people's initiative: co-operationbetween several supporters of this initiative and the tabloids: The campaign for the popularinitiative was distinguished by an extraordinary co-operation, i.e. between variousproponents of the popular initiative (especially the environmental organisations Global 2000and Greenpeace) and the tabloids led by the "Neue Kronen Zeitung", and its competitor, thepaper "täglich alles", also joined the sensationalist coverage of the topic of gene technology.Thus the popular initiative was supported by some of the most important Austriannewspapers from the very beginning. At the beginning of the campaign, the initiators stilltried to inform the public, but together with the tabloid newspapers the coverage of this topicturned into a succession of scary sensations and scandals. From the second half of 1996 to


the spring of 1997 the work "gene" increasingly became synonymous for "poison". Severalpeople from among the environmental groupings, however, also criticised this way ofcampaigning and advocated a delimitation from populist and falsified or falserepresentations. Unfortunately their criticism was widely disregarded.

Spring of 1997: Measures taken by the food and grocery stores with regards to geneticallymodified food: The largest Austrian food companies announced that they would exclusivelyplace food in their shelves that was guaranteed to be free of gene technology, and theydemanded that their suppliers promise to do the same. These announcements were knownas actionism since such overall demands can hardly be realised in the context of thecurrently existing conditions on the market as well as in the area of production. The onlypossible way to translate this idea into action would be a "positive labelling": Labelling ofproducts which are proven to be made without the use of any gene technological methods.

End of March 1997: Example for "actionism": so-called "genetic chocolate" scandal: The so-called "genetic chocolate" scandal occurred right before the people's initiative on genetechnology, which was at the height of public excitement (cf. Der Standard 03/26/1997,03/27/1997, 03/28/1997). Examinations had shown that the "Toblerone“ chocolate, which isproduced by the Kraft Jacobs Suchard Company and which is available in Austrian foodstores, contains lecithin made of GM-soya. The food chains Spar, Meinl and Billa announcedthat they would take the "Toblerone“ chocolate off their shelves for the time being. The foodchain Meinl wanted to destroy the affected stock of "Toblerone" right in its branches. Sincelecithin is a food additive, it does not have to labelled according to the labelling regulation forGM products (which had not yet been passed at that time). Therefore the reactions of thefood stores were partly thought to be too extreme.

Spring of 1997: Try to establish a positive labelling for food stuffs that are made without genetechnology: In connection with the public debate on the use of gene technology in the area offood production, Austria tries to establish a quality seal for food that is guaranteed to be freeof gene technology. Food chains (ADEG, Billa, Spar) and food producers (Kärntnermilch,Perlinger Naturprodukte, Toni's Freilandeier, etc.) reacted to consumer's rejections of genetechnology by establishing an alliance called "Arbeitsgemeinschaft für Gentechnik-freierzeugte Lebensmittel" (Association for foodstuffs made without gene technology) togetherwith environmental organisations (Greenpeace and Global 2000) and the Organic FarmersAssociation "Ernte für das Leben". The purpose of this unique co-operation between theeconomy and environmental organisations was the mutual development of quality standardsfor a positive labelling of food that is free of gene technology as well as the creation ofspecific conditions for the production and placing on the market of gene technology-freeproducts. Up to this point, however, only a very small amount of foodstuffs available arelabelled that way. Compared to the foodstuffs with positive labelling there is a vast amount offoodstuffs that are not labelled. The significance of this label is still only marginal. The greatcommitment of the commercial enterprises to offer only food without gene technology, as itwas announced loudly in the beginning, petered out rather fast.


April 7 to April 14, 1997: "Gene technology – Popular Initiative" – height of the publicexcitement about the topic of gene technology: The Austrian Popular Initiative on Genetechnology took place in the spring of 1997. The initiators of this popular initiative came fromdifferent ecological groupings: "ARGE Schöpfungsverantwortung" (Catholic environmentalproject), Österreichische Bergbauernvereinigung (Austrian Association of Highland Farmers),Tierschutzverein "Vier Pfoten" (Austrian Society for Prevention of Cruelty to Animals "FourPaws"), "Ökobüro" (Office for the Co-ordination of Austrian Environmental Organisations),Forum österreichischer WissenschafterInnen für Umweltschutz (Forum of Austrian Scientistsfor Environmental Protection) and the Green Party (Die Grünen: Austrian ecology party,which is represented in the Austrian Parliament since 1986).

The demands of Popular Initiative on Gene technology were as follows:

- a ban on the production, import, and sale of genetically modified food and agriculturalproducts that is embodied in a law

- the general ban of GMO releases (animals, plants, micro-organisms)- a ban on the patenting of any kind of living organisms

The Popular Initiative on Gene technology was very successful and even surpassed theinitiators' expectations. It was the second most successful popular initiative in Austrianhistory: 1,225.790 Austrians signed for it – that corresponds to 21.23 % of the people eligibleto vote at that time (Source: Federal Electoral Authority: Results of Popular Initiatives).

Early summer 1997: After the “Gene technology – Popular Initiative“: The FederalGovernment is faced with a difficult situation: After the popular initiative the FederalGovernment was faced with a very difficult situation since it was confronted with demands itwas hardly able or unable to meet:

(1) The demands of the Gene technology – Popular Initiative clearly violated the existing EUlaw. A total legal ban on releases in an EU member state would not be an adequateimplementation of the Deliberate Release Directive (90/220/EEC), which states that releaseshave to be authorised as long as they don't present a hazard to human health and to theenvironment (cf. Loibl/Stelzer 1997: 39).

(2) The demands of the Gene technology – Popular Initiative also somehow contradicted thePosition Paper on Gene technology by the Federal Government (March 1997). TheGovernment is rather open to innovation. Gene technology as a "new future technology"should be used for the benefit of the people, but has to be dealt with in a responsible way. Allthe necessary measures have to be taken in order to be able to use the new opportunities ofgene technology – this also applies to Austria as an economic location, to employment, andto the progress of research and development in Austria (cf. BKA/BMFV, BMwA et al. 1999).

The discussions focused on the following questions: The action range of the Austrianlegislation for the legal regulation of the use of gene technology, and the political ways todeal with the wishes of part of the population. In terms of internal politics, the FederalGovernment was faced with a deadlock situation between gene technology supporters and


gene technology opponents. Industry and research on the one side as well as theenvironmental organisations on the opposite side were not really willing to compromise. TheGovernment tried to take its stand between the to opposite poles, which resulted in the factthat the Government didn't follow a clear political course. This government strategy thereforedid not stabilise the situation, on the contrary, but it caused the Austrian policy on genetechnology to become rather rigid.

ðGene technology critics

Initiators of the popular initiative,media

óFederal Government

ïGene technology supporters


Accusation of the Government Argumentation Accusation of the Government

The government was not willingto meet the demands of Genetechnology – Popular Initiative.They would hide behind EUregulations and disregard thewishes of the voters.

The Government argued that thenational action range was limitedby the respective EU regulations.In order to support thesearguments the Governmentprocured an expert opinion (cf.Loibl/Stelzer 1997).

Within the context of the failedrelease applications theGovernment was still accused ofbeing too lenient with theextensive "technologypessimism".

Autumn of 1997: Special Parliamentary Committee for a prior discussion of the “Gen-Technology – Popular Initiative": A Special Parliamentary Committee was established thatshould draw up a strategy on how to deal with the demands of the popular initiative on genetechnology in the Parliament. It consisted of representatives of the parliamentary parties(SPÖ – Social Democratic Party, ÖVP – People's Party, FPÖ – Freedom Party, Grüne –Green Party, LIF – Liberal Forum), if necessary, also people who are responsible for a givendepartment, and the authorised representative of the popular initiative on gene technologyPeter Weish (Forum österreichischer Wissenschaftler für den Umweltschutz – Forum ofAustrian Scientist for Environmental Protection). Besides that, several experts andinformants (including representatives of the organisations who initiated the people's initiative)and experts who were nominated by the Parties (some of them from the ParliamentaryInquiry Commission – parlamentarische Enquete-Kommission 1992) were invited to speak.The talks between the experts, the representatives of the initiators of the people's initiative,the Government, and the opposition parties turned out to be extremely conflictive.

October 1997: Concept Eco-Country Austria: The Minister for Agriculture presents a "new"Austrian concept, which is based on the concept of eco-social market economy – to enforceecological developments with market economic tools and keep an eye on basic socialconditions. According to the Minister, one of the most important developments in this eco-country concept is among others the ecologisation of Austrian agriculture and the rejection ofgene technology in the area of food production (cf. Molterer 1997).

November 1997: Austria consents to the EU patent regulation: The Austrian Federal Ministerfor Economic Affairs joined the majority in the European Council of Ministers and voted forthe EU patent regulation. This means that the third demand of the popular initiative on genetechnology won't be met either. In this case, the wishes of research and industry were


fulfilled. In terms of internal policy, it seems as if the Federal Government is unable toembark on a clear political course in the area of gene technology.

December 1997 – January 1998: Public debate and failure of the the 5th GMO releaseapplication – the public debate does not calm down – resumption of the controversy twoyears prior, with the same respective roles:

Applicant: Pioneer Saaten GesmbH

GMO: GM Bt-maize which is resistant to insects. Application for the admittance of thisspecific variety and thus for its release

At the end of 1997, the seed producer Pioneer handed in a release application for geneticallymodified maize which again caused quite a lot of public unrest. The responsible FederalMinister was not happy about this action and announced that the application would bethoroughly examined. Pioneer was also heavily criticised by both the environmentalorganisations Greenpeace and Global 2000 as well as and by the President of the SpecialParliamentary Committee.

This led to the resumption of the controversy two years prior to that occasion with the samerespective roles (see public debate about the 1st application and the 2nd application): Stateand Municipal politicians protested the planned release by Pioneer. At the beginning of thedeadline for the evaluation in January 1998, the Green Party, together with severalenvironmental organisations, started a counter-campaign. Greenpeace and Global 2000mobilised the population by means of forms containing pre-written objections. They wereagain supported by tabloid newspapers, i.e. by the "Neue Kronen Zeitung" in particular. Justlike in 1996, gene technology became the main topic in the tabloids. The notifier – Pioneer –pointed out that they could not understand the excitement of the population about thisrelease application.

ðGene technology critics:

Initiators of the popular initiativemedia

óResponsible Federal Minister

ïGene technology supporters:Industry and research Gene

technology

Accusation of the FederalMinister: Idleness and

incompetence

Announcement Accusation of the FederalMinister: Idleness and

incompetence

Demands for a legal releasemoratorium

thorough examination of theapplication and possibly thedecision not to authorise the

release

Pioneer states that the result isprejudiced due to a lack of

fairness.

ñGene technology supporters, gene technology opponents, media, Federal Minister for Agriculture

Gentechnik-

joint criticism of the Federal Minister

Criticism is aimed towards the unacceptable action to announce a negative outcome, even before the endof the legally prescribed procedure. This led to the accusation that it disregarded constitutional principles.


Finally, Pioneer withdrew the release application. The publicly successful counter-campaignwhich was initiated by environmental organisations culminated in the occupation of thePioneer headquarters by gene technology activists, which was meant to prevent thedistribution of GM maize seeds. Another reason for the failure was the fact that the formalstructure of the application was inadequate. Pioneer again criticised the Minister andannounced to hand in new release applications. This, however, has not been done so far.

January 1998: Advisory Board on Gene technology recommends active safety research: Inconnection with the risks involved in trial releases, the Advisory Board on Gene technologyrecommends that project-oriented safety research should be encouraged. In compliance withboth strictly controlled conditions as well as strict safety regulations, the trial releases oftransgenic plants should be carried out on a small area. Within the context of a comparativeanalysis, the initial plant should be cultivated and examined in conventional and biologicalagriculture (Resolution by the Advisory Board on Gene technology, 1998 in:BKA/BMFK/BMWV 1999).

Autumn of 1997 – May 1998: Debates on the Amendment of the Gene technology Act andthe change of the GTG: The debates on the change of the Gene technology Act alsofollowed the same usual patterns. When the Minister dispatched a draft of the Amendment inDecember 1997 this solo attempt once more led to heavy criticism in the Parliament and inthe Special Parliamentary Committee for Gene technology. The Special Committee whichwas established to discuss the strategies for dealing with the demands of the Genetechnology – Popular Initiative, was confronted with a completed bill.

Spring of 1998: Establishment of the Forum Biotechnology: Various enterprises from thefood and seed sector join forces as a reaction to the public controversies in connection withthe popular initiative on gene technology. The forum was intended to offer acommon/undivided organ of the biotechnological industry in public debates. The Forum aimsto bring about an understanding and acceptance of bio- and gene technological processes inthe agricultural and food sector by means of extensive and objective discussions (cf. Chapter3.2.9).

May 1998: The Amendment of the Gene technology Act 1998 is passed:

Main points of the Amendment of the Gene technology Act 1998 (BGBl. I Nr. 73/1998):

- Multi-party procedure: Party status in procedures to authorise the release of GMOs also applies to themunicipality where the release takes place and to neighbouring municipalities; property owner,neighbours, government of the Province (Bundesland).

- Transparency should be increased by:o an extended public accessibility of the notification documents and by a better announcement of the

release applications;o the nomination of experts should be based on a public invitation to make suggestionso the creation of a publicly accessible Register of products containing GMOs (Gentechnikregister)

- New experts for all the scientific committees and adding five experts to the scientific committee forreleases and the placement on the market of GMOs who deal with ecological questions

- Safety documentation: Creating an institution that collects data on the safety of GMOs.


- Measures in case of an unauthorised release: Stricter penalties for the illegal release of placement onthe market of GMOs

- Creating specific liability regulations for the release and work with GMOs: o Introducing a liability for damages that is independent of the actual cause

(verschuldensunabhängige Gefährdungshaftung)o Coverage: The notifier has to get a liability insurance that covers risky operations both using

GMOs as well as the release of GMOs.o Two easements for the affected parties facilitation of evidence (Beweiserleichterung) and the right

to obtain informationo Liability also includes material damages that may lead to environmental hazards.o Restoration of the environment in case of any destruction: the responsible authority can demand a

sanitation at the expense of the notifier.

According to the Government this Amendment of the Gene technology Act was a concessionto those who were opposed to gene technology. The change of this GTG was dissatisfactoryfor both the opponents and supporters of gene technology.


Environmentalist groupingsparliamentary opposition

óFederal

Government



Criticism of the billð

Amendment ofthe Gene

technology Act

Criticism of the billï

The dangers of gene technology requireadequate regulations. A change of theGene technology Act would not solvethe problems with releases. There arestill the same demands for a legal banon releases or for a five-yearmoratorium respectively.

Warning against unreasonablerestrictions. The bill is not in accordancewith the future principle in the GTA, andserious problems for R&D can beexpected.

The Amendment of the GTG was merelyan attempt by the government to meetthe minimum demands made by theinitiators of the popular initiative. At leastthe hearing of the people affected by therelease of GMOs was brought aboutand the structure of scientificcommittees was rearranged. In general,the opponents of gene technologyargued that the original GTA was onlyslightly changed (cf. Langthaler/Nohel1998).

They fear that the Amendment createsserious disadvantages for the Austrianeconomy and that Austria will take theposition of an outsider within the EU.They mainly criticised the expansion ofthe hearing procedure and the liabilityregulations. Especially the regulation ofliability insurance, which would make itpractically impossible for researchinstitutes and universities to work withGMO, would force these institutions tomove their activities to another country(cf. Ruckenbauer 1998)

December 1998: GM-Seed Labeling Regulation: During Austria's EU presidency, anextensive Europe-wide seed package is passed, which apart from labeling regulations forGM-seed also contains regulations for the placing on the market of plant-genetic resources (Council Directive 98/95/EC). This EU regulation is incorporated into Austrian law with the


implementation of the Ordinance on Labelling of Genetically Modified Seed (Saatgut-Gentechnik-Kennzeichnungsverordung, BGBl.II Nr. 74/1999).

January – Spring of 1999: Debate on possible plans for trial releases by AgrEvo andPioneer: In January 1999, the environmental organization Global 2000 was worried that thetwo companies Pioneer and AgrEvo might also plant GM maize in Austria, which they arenow authorized to do throughout Europe – thid by "entering through the back door", so tosay. The Green Party, as well as the environmental organizations Global 2000 andGreenpeace, called on the companies and on the Minister for Agriculture to disclose therespective plans. Although the companies denied the existence of the so-called "secretgenetic experiments", the discussion did not quiet down. The confrontation reached its heightin the occupation of the company headquarters of AgrEvo. Together with organic farmers,Greenpeace started a protest campaign in Carinthia. At the beginning of April, the tempestsubsided after the Forum Biotechnology had declared that the industry would not releaseany GM-maize in 199945.

Spring of 1999: Import ban on GM maize from Monsanto: With very little reaction from themedia, the Minister for Consumer Protection imposed a ban on the placing on the market ofGM-maize from the company of Monsanto (VO 175/1999). The Forum Biotechnology and theseed group were rather unhappy about the Minister's decision. The research site Austriawould thus continue to lose significance46. The media only showed a minor reaction on theimport ban.

Summer of 1999: "Feeding stuff scandal" – fodder was found to contain GM-soya – publicdebate flares up again in the summer of 1999: In the summer of 1999, the Green Partyordered the Environment Agency to find out whether fodder contained or consisted of GMOs. Some of the fodder products proved to contain GM-soya. The gene technology critics – theGreen Party, environmental organizations – but also the Federal Minister for ConsumerProtection, called on the Minister for Agriculture to put through an obligatory labeling offodder containing or consisting of GMOs. Similar to the Novel-Food Regulation and the so-called Novel-Seed Regulation they also demand a Novel-Feed Regulation47. As to the areaof agriculture, the President of the Chamber of Agriculture in the Tyrol pointed out that in

45 Sources: APA068 27.01.99, APA287 27.01.99, APA295 27.01.99, APA485 27.01.99, APA68427.01.99, APA485 27.01.99, APA/OTS082 27.01.99, APA/OTS114 27.01.99, APA/OTS115 27.01.99,APA/OTS194 27.01.99, APA/OTS211 27.01.99, APA/OTS250, 27.01.99, APA/OTS273 27.01.99,APA012 05.02.99, APA184 09.02.99, APA419 09.02.99, APA/OTS154 09.02.99, APA13410.02.99,APA202 10.02.99, APA319 10.02.99,APA396 10.02.99, APA/OTS145 10.02.99,APA/OTS196 10.02.99, APA475 22.02.99, APA/OTS193 22.02.99, APA388 25.02.99, APA32203.03.99, APA510 03.03.99, APA554 03.03.99, APA/OTS039 03.03.99, APA/OTS158 03.03.99,APA/OTS170 03.03.99, APA/OTS229 03.03.99, APA/OTS230 03.03.99, APA/OTS241 03.03.99,APA349 04.03.99, APA431 04.03.99, APA/OTS 04.03.99, APA/OTS231 04.03.99, APA268 05.03.99,APA451 03.03.99, APA/OTS152 05.03.99, APA200 08.04.99, APA257 08.04.99, APA/OTS10508.04.99,APA/OTS138 08.04.99, APA/OTS173 08.04.99.

46 Sources: APA/OTS244 28.05.99, APA349 28.05.99, APA394 28.05.989, APA/OTS029 29.05.99,APA179 29.05.99, Der Standard 28.05.99:10.

47 Sources: APA100 29.07.99, APA/OTS131 29.07.99, APA/OTS171 29.07.99, APA/OTS231 29.07.99,APA/OTS217 29.07.99, APA/OTS592 29.07.99, APA/OTS169 30.07.99, APA/OTS174 30.07.99,APA/OTS034 01.08.99, APA/OTS042 06.08.99, APA249 09.08.99, APA/OTS044 30.08.99.


order to protect farmers and consumers there ought to be more control of food and fodderwith regard to GM ingredients (APA134 09.08.99). The findings of GM-soya in fodder gaverise to a renewed media interest in the topic of gene technology in agriculture andfoodstuffs48.

Autumn of 1999: Gene technology becomes an issue in the Federal Parliament electioncampaign in 1999: The Federal Chancellor and the leader of the Social Democratic Party –SPÖ at that time, gets the environmental activist and expert on gene technology from theenvironmental organization Global 2000 for his campaign team as a candidate for theFederal Parliament (Der Standard 08/23/1999). A few days prior to the election, the FederalChancellor declares in a letter to the largest Austrian environmental organizations Global2000, Greenpeace, and the WWF (World Wildlife Fund) that Austria will refrain from thecultivation of GM plants on its territory (Source: Letter by the Federal Chancellor toGreenpeace, the WWF and Global 2000, September 27th, 1999).

Autumn of 1999: New discussion about a planned deliberate release application within thecontext of a scientific safety research project: November 1999 gave rise to a new discussionabout a planned risk and safety research project by the University of Agricultural Science(Universität für Bodenkultur – BOKU), which would have the purpose to characterize GMfruit-trees (apricot and cherry trees) and examine direct and indirect biologicalinterdependencies. The intended research should be paid for by the Federal Ministry forScience and Research – BMWV and the Federal Ministry for Agriculture and Forestry –BMLF. The planned project caused some turmoil because – after a trial phase in containedsystems – another part of the examination should be carried out in an open area, on thecondition that the research findings would imply that there wouldn't be any negative effectson the safety of the environment.


Global 2000Greenpeace

The trial releases would represent a broken electoral promise formerly made bythe Federal Chancellor. This application would also "open the doors" for therelease of GMOs for commercial purposes; the research of gene technologicalrisks doesn't need any trial releases; the gene technology critics (e.g.environmental organizations) were not integrated into any of the preparatoryphases of the project; demand for the publication of project records (cf. APA43224.01.99, APA/OTS210 24.11.99, APA327 25.11.99, APA/OTS200 25.11.99,APA/OTS280 25.11.99, ).

Green Party The project is disguised as a safety research project and should thus pave the wayfor commercial releases as well as for the use of gene technology in the area ofagriculture. Announcement of massive protest measures. The project funds shouldbe used for bio-agriculture. Accusation of the Minister for Science: The declarationas a safety research project represents circumvention of the responsible FederalChancellery/Federal Ministry for Women's Affairs and Consumer Protection. Accusation of the Minister for Agriculture: On the one hand he propagates the"Eco-Country Austria", and on the other hand he supports the lobby for genetechnology (cf. APA432 24.01.99, APA/OTS179 24.11.99, APA/OTS217 25.11.99,

48 For example: Neue Kronen Zeitung 29.07.99, 30.07.99, 31.07.99, 05.08.99, 07.08.99, 10.08.99; DerStandard 20.07.1999, 30.07.1999, 31.07.1999.


APA/OTS570 25.11.99).

Expert on genetechnology of theSPÖ

The second thoughts of the Austrian population about gene technology in the areaof agriculture have to be taken seriously. Any promises with regard to GMOreleases are a "wrong signal". Research in the field of gene technology – yes,releases – no; safety research is also possible in the greenhouse (cf. APA43224.01.99, APA/OTS212 24.11.99, APA/OTS232 25.11.99).

Environmentalspokesman of theFPÖ

The release that is disguised as a safety projects should only make the genetechnology lobby happy; no tax money should be used for releases until the effectsare absolutely clear (cf. APA327 25.11.99, APA/OTS173 25.11.99).

Reactions to the criticisms

Scientists at theBOKU

Clarification: No releases are planned at this point; Purpose of the project:Assessment of the effects of genetic transfers to plant ingredients, to non-transgenic related plants, to insects and ground organisms in a permanentlycontrolled environment; external project supervision by independent authorities;project is not influenced by any industry; the preparatory phase also incorporatedorganizations with a critical view on gene technology (e.g. Global 2000) (cf.APA554 24.11.99, APA359 25.11.99).

Academy ofScience

Group of international experts responsible for the control of the different stages ofthe project; representatives of various relevant NGOs are also involved in theprocess (cf. APA/OTS197 15.12.99).

Minister forAgriculture

Risk assessment project; one can not talk about risks if they are unknown, ifresearch is prohibited (cf. Die Presse 25.11.99).

Minister for Science It is necessary to research the risks; the project does not aim at any industrialreleases; at this point there are no plans for any kind of releases (cf. APA/OTS24825.11.99).

Minister forConsumerProtection

demands more time to think about this issue (cf. Neue Kronen Zeitung 15.12.99).

Federal Chancellor Research – yes, releases – no; more transparency and intensive dialogue in thefuture (cf. Neue Kronen Zeitung 16.12.99).

Role of the media

Neue KronenZeitung(tabloid newspaper)

Just like in 1996 and 1997, the media supports the standpoint of the environmentalorganizations and talks about "secret plans" made by the Minister for Science.However, gene technology is no longer the main topic. Instead, the formation ofthe new government has become the most important issue (cf. Neue KronenZeitung 14.12.99, 15.12.99, 16.12.99).

Der Standard(high qualitynewspaper)

The column called "Kommentar der Anderen“ ("Other People's Comments") isused by scientists as a public arena for this controversy (cf. Der Standard12/02/1999; 12/04/1999, 12/05/1999).


Résumé: Rigidity of the Austrian policy on gene technology – since 1996 de-facto releasemoratorium – Federal Government between the lines: Since the so-called "illegal" release in1996 and the following popular initiative on gene technology, the different positions within theAustrian policy on gene technology are at a deadlock, and the Austrian policy on genetechnology finds itself in a rigid state. A political re-organisation has not yet succeeded. Sincethe beginning of this debate, a kind of de-facto release moratorium exists in Austria. Newattempts to hand in applications for the release of GMOs have already failed before theofficial notification could be made. Even though it is theoretically possible for the industry tohand in new applications any time, none are expected in the near future, due to the politicalsituation in Austria.

Present situation in Austria: "a deadlock"


Environmentalist groupingsparliamentary opposition

óFederal Government



Criticism of the de-facto moratorium:

the unofficial character of the de-factomoratorium is criticised

de-facto releasemoratorium

Criticism of the de-facto moratorium:

Federal Government is not impartial tothe trial releases and tries to preventthem

Massive protests are expected again whenever the GMOs are actually released into theenvironment, but it is difficult to predict the intensity of the new public debate. The rigidpositions of the individual activist groups give rise to the assumption that it will be verydifficult to lead the national policy on gene technology out of the current "one-way street"(Grabner 1999: 319).

3.4 Prospects for the Sector

Opportunities and barriers for the development of biotechnology of the sector:

The interviewed companies and research institutions were also asked for the factors that, intheir opinion, either impede or further the development of a "modern" biotechnology (suppor-ted by gene technology) in Austria.

It strikes that, except for one company, none of the companies that actually work in theAustrian the bio-/gene technological area in the agricultural and food sector answered thequestion about impeding or furthering factors. The company that answered the question hadhanded in an application for the deliberate release of GMOs, which was rejected in 1996.Seed and food processing companies, which are currently not using any gene technology inproduction and development respectively but would still like to do research or work in thisarea in Austria, were also asked about the impeding or furthering factors. Some of thesecompanies joined forces in the Forum Biotechnology (cf. Chapter 3.2.9). Some of the


companies of the Forum Biotechnology were interviewed face-to-face or over the phone (3multinational seed producing and 3 food manufacturing companies).

According to the companies, the following factors impede development (list and summary ofarguments): Due to the public discussions about the applications of field releases of GMOs(cf. Chapter 3.3.4) an initially objective discussion turned into a public political debate, whichnow showed a lack of objective argumentation. "Populism", "sweeping statements", and the"creation of fear" would hamper any development in the agricultural and food sector. Themedia seems to do a bad job in informing the people, instead they convey anundifferentiated picture of the use of gene technology – good for medical purposes, bad foragriculture and food – and thus increase the latent scepticism and rejection. The opponentsof gene technology demand safety research projects, but at the same time they also try toprevent them. Contrary to the use of gene technology in the area of medicine, theconsumers are less likely to recognize the immediate benefits of gene technology in theagricultural or food sector. It is more difficult to communicate the advantages of genetechnology in agriculture of food production. According to the food production companies,this may be blamed on the agricultural industry, which has failed to produce products thatwould present a direct benefit to the consumers (e.g. tomatoes with an anti-cancer gene). Aslong as the population or the consumers reject gene technology in agriculture and foodprocessing, the industry will not produce such products or place them on the market. Thereis a lack of support by politicians and decision-makers, who should show more "commitment"and "decisive power". In this connection, the fact is criticized that the final decisions for oragainst releases in Austria are made by the politicians, which makes the outcome verydependent upon the every-day political opinion. The basic legal conditions that are muchmore restricted than in other countries and the bigger bureaucratic obstacles, also present agreat disadvantage. It is pointed out that Austria does not have any large companies in theagricultural and food sector, which is why, compared to other countries, the industry findsitself in a rather weak position.

According to the companies the main furthering factor for the development of bio- and genetechnology in this sector are the Austrian research activities, whose quality level is very highin comparison with other countries.

Also the research institutes in the agricultural and food sector were questioned aboutimpeding or furthering factors. Eight of the research institutes answered the question.According to them, the following factors further or impede the development of a modernbiotechnology (list and summery of arguments). The research institutes were unhappy aboutthe "sensitive political climate" in Austria, where society follows the "principle of mistrust"rather than the "principle of trust" in connection with biotechnological research anddevelopment in the agricultural and food sector. The research institutes believe that one ofthe reasons for this strong rejection is the low level of knowledge among the population.People are thus unable to assess the possible advantages and problems of gene technologyin a realistic way. Some of the media and groups who are actively opposing gene technologyare said to have a rather tendentious information policy which would further rejection. Thepositive development of bio- and gene technology is also hampered by the non-uniform


actions of political decision-makers. There is a lack of clear political commitment to thedevelopment of biotechnology and gene technology in particular. That's why there are nospecific (political) research concepts in this sector, and there is a special lack of basic, solid,long-term financial support for public research facilities. The number of research institutionsin this sector is said to be too small, one may say that the critical mass for successfuldevelopment is lacking. The fact that there is no "industrial back-up area" in Austria seems tobe another problem. Besides that, there is not enough available research capital, sinceAustria does not have any kind of scientific or technological culture. The restrictive legislationand policy in Austria also presents a location disadvantage of Austria for researchinstitutions. The research institutions would be happy to increase the co-operation with theindustry, and the national and international industry is also interested in research co-operations and research projects. However, their offers have to be declined because of thecritical political and social climate in Austria. All in all, there is a lack of practical and socialdesire to accept, encourage and use the benefits of basic and applied research in the area ofbiotechnology.

According to the research institutes, the most important furthering factors for thedevelopment of bio- and gene technology include the high quality of research in spite of thelow level of financial support. Individual support institutions such as the FFF and FWF arealso said to be positive. Another furthering factor would be personal initiative, e.g.establishing one's own company. The research institutions especially point out thatinternational networks and research co-operations with other research institutions andcompanies in other countries also present a great advantage.

Prospects for the development of biotechnology of the agricultural and food sector:

Concerning the prospect of the sector, there will be no greater change in the next few years.Both the research sector and the industry believe that no GMOs will be released in the nextfew years in Austria. A way out of the situation is seen in finding alternative areas ofapplication and in finding and occupying niches. Some research organisations, for example,see a way out in acting pragmatically and diversify in areas of biotechnological research anddevelopment with a higher public acceptance and, more importantly, a higher acceptance offunding organizations. There are attempts of doing research for the pharmaceutical sectorusing plant bio-/gene technology. Also, chances for the use of gene technology in agricultureare seen in the area of the development of novel renewable resources for industrial use. Anexample for the strategy of finding and occupying niches is given by a research institution,which is internationally known for its research on bio catalysis.

In its First Report, the Advisory Board on Gene technology (cf. BKA/BMFV 1999)emphasised the need for the transparency of the chances, aims and possible risks of genetechnological research and development, as well as the need for a responsible way ofdealing with the possible risks represented by science and economy. Preventing theapplication of this new technology would be a missed chance to slowly gain someexperience with it and to pursue safety and risks suitable for the Austrian realities.Furthermore, the Advisory Board claims for the support of the foundation of companies


working in the bio- and gene technological area, which, through direct co-operation betweenacademic research and the industry, translate scientific results to into action.


4 Equipment and Supplies


In our survey (cf. chapter 1) no public funding agency reported funding activities in theequipment and supply sector from 1994-1998 or for any special programmes foruniversity/industry research collaboration in this sector. However, according to arepresentative of an Austrian equipment firm, the FFF is also active in the equipment andsupply sector and for him "is absolutely the institution to turn to" (personal communication).Given the fact, that according to the FFF 90% of its biotechnology funds are dedicated tobiopharmaceuticals (personal communication), this amount is relatively modestly withestimated at less than EURO 770 000. In summary, according to our survey there is almostno public funding for this sector in Austria.

The survey on research organisations (cf. chapter 2.1.2) showed little PSR activity in thissector. Only one public research institute in Vienna reported that – among its activities inbiopharmaceuticals, agro-food and environment research – it would be active in theequipment and supplies sector. This institute is co-operating in more than 30 current projectswith domestic, European and US-American companies and public research institutes. Theinstitute employs about 20 people in this sector and awarded between 1994 to 1999 ca. 20masters and 16 PhD degrees for work in the equipment and supply sector.


In our survey (cf. chapter 2.2) six responding firms reported that they were active in theequipment and supplies sector. However, only four of them gave more detailed informationabout the company and their activities. This small number of firms corresponds with expertopinions. Although the interviewed experts from research and industry could not verify theexact number of companies, they confirmed the general picture of relatively few active firms(personal communication December 12th, 1999; February 24th, 2000). The following tablegives an overview of the four responding companies.


Table 33: General Overview on Responding Firms Active in the Equipment andSupplies Sector

A B C D

Activities Antibodies

Reagents used inimmunology andcell biology

Kits forimmunology andcell biology

Centrifuges, filters,fermenters, cellbreeding,antibiotics andinhibitors, bacterialand yeast strains,media forpropagation ofbacteria, yeast,phage as well asindustrial encymes

High quality, highperformanceinstruments(cell culture,separationtechnology)

Filters, genetransfer systems,enzymes fornucleid acidresearch, kits formolecular biology,antibodies,reagents used inimmunology, kitsfor immunology,reagents used forprotein chemistry,cross-linker,detergents, kits forprotein chemistry,protein standards,molecular-weightmarkers andreagents used incell biology

Year ofestablishment

1998 1921 1922 1974

No. of employees 1-20 51- 100 400 World-wide 1-20

No. of R&D staff 2 5 50 0

Turnover in EURO 1.1 Mio 23 Mio No data. 1 %originate frombiotechnology

Main market World-wide Europe USA For the Austrianbranch: Austria

Source: own survey 1999/2000

Given the small number, we will describe the firms also individually.

Firm A produces antibodies, reagents used in immunology, kits for immunology, reagentsused in cell biology and kits for cell biology. The firm was established in 1998 as anindependent enterprise. The small company employs between 1 and 20 persons (two ofthem occupied with R&D) and produced a turnover of 1.1 Mio EURO in 1998.The company is active in product development and has ca. 300 supply products on themarket. At present the company is active with R&D of 15 supply products. The firm isprimarily operating on the world market.The firm co-operates with several public as well as private research institutes in Austria,Europe and the USA. The company accrues as well as pays royalties. Product licensestaken are mainly US-American and European of origin, however, there is also one Austrian


and one from another country. The firm has taken a license for one US-American technology(IHS-Survey 1999/2000).

Firm B was established in 1921 as an independent enterprise and is active in the field ofcentrifuges, filters, fermenters, cell breeding, antibiotics and inhibitors, bacterial and yeaststrains, media for propagation of bacteria, yeast, phage as well as industrial encymes. Thefirm is active in planing and installing plants for the agrofood and pharmaceutical sector andemploys between 51 and 100 people, of which 5 are active in product development. Atpresent, the company is developing three products for the equipment sector. The mainmarket for its products is Europe.The firm co-operates continuously with an Austrian university research institute. Manyemployees have graduated at this university institute. Furthermore they co-operate withother domestic and international universities on project basis. It holds more than 40 patents,ca. half of them are Austrian, one quarter European, the rest being US-American and patentsin other countries. The company accrues royalties from licenses. In 1998 the company had aturnover of 23 Mio. EURO, all attributed to its biotechnology activities. They have an exportshare of 87% (IHS-Survey 1999/2000 and personal communication February 24th, 2000).

Firm C was established in 1922 as a independent enterprise and is active in the productionof high quality, high performance instruments (cell culture, separation technology). It employsworld-wide about 400 people, 50 of them active in product development. At present it hasone biotechnology product on the market, the main market being the USA. They co-operatewith two public (Austrian, US-American) and two private (European, US-American) researchinstitutes. The company does not accrue royalties, it has licensing agreements with twoAustrian, European and US-American companies each. The firm did not provide data on itsturnover, of which less than 1% originate from its biotechnology activities (IHS-Survey1999/2000, internet-recherche).

Firm D was established in 1974 as an independent enterprise and is active in the field offilters, gene transfer systems, enzymes for nucleid acid research, kits for molecular biology,antibodies, reagents used in immunology, kits for immunology, reagents used for proteinchemistry, cross-linker, detergents, kits for protein chemistry, protein standards, molecular-weight markers and reagents used in cell biology. This small company employs between 1and 20 people, however, none of them are active in R&D. Nevertheless, the company isactive in product research, product development and technology development. They havemore than 100 products for equipment as well as more than 100 supply products on themarket, the main market for the Austrian branch being Austria (IHS-Survey 1999/2000).


The main reason the interviewed experts gave for the small number of Austrian firms in theequipment and supplies sector, is the rather limited Austrian market for equipment andsupply: "In Austria there are only three to four big companies, the three big Bs: Biochemie


Kundl, Baxter and Bender, and there is a group of investors, which think in somehow smallerscales. And actually, that’s it around the pharmaceutical area" (personal communicationFebruary, 24th 2000). According to this expert from the industry many producers in the agro-food sector would buy only components for the extension of their plants and would do theplanning on their own. Because of the small market ("the country and the investments aresmall"), Austrian equipment and supply firms would depend very strongly on export."Therefore the companies have to move into export and only a few can survive and manydie, because they moved into export" (personal communication February 24th, 2000).Another expert from university research shares this opinion and states, that Austria wouldlack the "industrial back-up area" for the equipment and supply sector (personalcommunication December 12th, 1999). Regarding the laboratory equipment the expertsinterviewed agree that most equipment is imported and that Austrian companies in this sub-sector are primarily trading companies.

It is hard to delineate the equipment and supply sector from sectors such as engineering andsteel. Beside firms which are primarily or solely dedicated to biotechnology, the equipmentsector comprises also of companies, which offer their highly specialised products or servicesnot only to the biotechnology sector, e.g. special steel. These firms do not necessarilyconsider themselves as bioechnology companies. A quotation from an interview with arepresentative from a big Austrian biotechnology firm illustrates this: "We are doing our ownplanning for the big fermenters. This is in-house-planning and it is realised with differentfirms. (…) Naturally, there's a great deal of infrastructure around such a fermenter vat, andthere is a great deal of plumbing, probes, electric lines and so forth. And naturally there areAustrian companies which are doing that." These companies “get their contract from ageneral contractor to weld the vat. They have no product in biotechnology, but they areproducing vats” (personal communication March 27th, 2000).

4.4 Prospect for the Sector

One interviewed expert from university, who quitted research in the equipment and supplysectors several years ago, saw little prospects for the sector because of the lack of Austrianbiotechnology industry and lack of financial support from the public sector. A companyrepresentative, however, was less pessimistic and assumes a reasonable growth in thissector, also because of the current governmental and municipal initiatives to promotebiotechnology start-ups (personal communication Moser December 12th, 1999; SodeckFebruary 24th, 2000).

One promoting factor stressed clearly from industry is internationally competitive PSR(personal communication with an expert). Positive factors, indicated by an expert fromuniversity are networking with foreign companies and R&D institutions, initiative like start-upsfrom university as well as the funding organisations FFF and FWF (own survey 1999/2000).


Experts from university indicated the following hampering factors: opposition of NGOs in theagro-food sector, an attitude in government of postponing decisions, lack of venture capital,lack of determined, adequate and continuous funds (own survey), and the difficult position ofthe sector giving traditional funding guidelines, i.e. the research phase which is much lessfundamental and applied at the same time which prohibits funding from FWF (fundamentalresearch) and a private firm (application orientated) as well.


5 Comparing the Three Sectors

Within Part V, four different groups of results will be presented, namely (1) a statisticalsummary of the biotechnology sector in Austria, (2) an overall summary of the threebiotechnology sectors, (3) a comparison of the similarities and differences between the threesectors and, finally (4) a theoretical assessment of the relevance of the empirical findings forAustria for the four main theoretical approaches to industrial innovation research.

5.1 Biotechnology in Austria: A Summary of Key-Indicators

Table 34 offers a comprehensive summary of the three biotechnology sectors in Austria, aswell as of their combined dimensions. Table 34 is separated into three main parts whichcover the science base (Part I), the industrial structure (Part II) and the public acceptance(Part III).

Part I: the Science Base (human resources, funds, funding organizations, significance ofprogrammes, EU-programmes)

Part II: Industrial Structure (company population, new companies, significance of multi-nationals, size distribution of companies, turnover, location of main PSR-collaborators,location of main company collaborators, significance of Business Interest-NGOs)

Part III: Public Acceptance (acceptance of biotechnological products/biotechnologies,regulation, significance of Public Interest-NGOs)

Even a brief glance at the three parts of Table 34, reveals that the three biotechnology-sectors exhibit a very different profile with respect to all three main areas. Thus, a strikingdissimilarity across the Austrian biotechnology segment can be identified, which will lie at thecore of the subsequent assessments in chapters 5.3 and 5.4.


5.2 Summary of the Three Biotechnology Sectors in Austria

5.2.1 Biopharmaceutical Sector

(1) Main characteristics of the sector

The Austrian pharmaceutical industry is only of minor importance when evaluated in anEuropean perspective. Despite its comparatively high productivity, the overall production ofthe pharmaceutical industry is small in comparison with most EBIS partner countries.Austrian pharmaceutical industry employs less people than most EBIS partner countries.This fact must be born in mind when considering the competitive position of Austrianindustrial biopharmaceutical research and its necessary "critical mass". In addition, the shareof pharmaceutical industry on total employment is smaller than in five EBIS partnercountries. Moreover, Austria is a net-importer of pharmaceuticals and its industry consistsmainly of small and medium sized enterprises.

In our survey, we identified 22 research institutes active in biopharmaceutical research with astaff of 617 researchers. The responding institutes granted between 1994 and 1998 a total of135 first-level university degrees and 127 PhD degrees for research topics related tobiopharmaceuticals.

Public funding of biopharmaceutical research had a share of 69% of all biotechnologyfunding. Public funding organisations financing biopharmaceutical research between 1994and 1998 are the BMWV, the FFF, the FWF, the ÖNB, the Innovation Agency, the City ofVienna, and (with comparatively small financial contributions) several Austrian Federal Statesoutside Vienna. There was no special public programme for biopharmaceuticals. Publicfunding of biopharmaceutical research was executed within the regular instruments offunding organisations. Recently several initiatives have been started to increase research inand technology transfer of biopharmaceutical research (e.g. Tecma, Impulse ProgrammeBiotechnology, establishment of a "competence center").

In our survey we could identify 13 firms actively engaged in biopharmaceutical research. It issafe to assume that this number does not include all existing firms. Most firms are small andmedium sized, only four have more than 500 employees. Austrian firms are mainly in foreignownership and export-oriented, only one firm considered the domestic market as mostimportant for its products.

(2) Leading forces of the whole sector

The estimated total turnover of pharmaceutical products for human medicine in 1996 was1 257 MECU (based on wholesale prices). The market for biopharmaceuticals is highlyregulated by national and European legislation. Currently, essential features of thebiopharmaceutical sector and its wider environment include a regulated market entrance,buyer monopoly (statutory health insurance), a severe financial crisis of the health care


system, friendly consumer attitudes, an extensive regulation and no public controversies onxenotransplantation.

(3) Leading forces for biotech part of the sector

The leading force of the biopharmaceutical sector is clearly a substantial – internationallyintegrated – university system (including university clinics), a number of large internationalcompanies with Austrian R&D facilities, a small number of start-up firms as well as a readilyavailable highly qualified human potential. Another – more recent – leading force isincreasing political support by the Government and municipal initiatives to increaseawareness for company creation and RSR/private co-operation in biotechnology. Most ofthese initiatives are taken up by the biopharmaceutical sector.

In recent years, several funding initiatives from the Federal Government and the ProvincialGovernment of Vienna (special programmes) have been identified and which point to the factthat the political support for this sector is increasing.

(4) Inhibiting forces for biotech part of the sector

Our survey, as well as the literature, indicate a number of hampering factors for thedevelopment of the biopharmaceutical sector on the macro-, meso and on the micro-level:Among them, lack of funds, lack of public acceptance and weak political support are themost prominent constraints. Other important barriers include the attitude towards patentingby Austrian researchers (preference for publishing), a lack of entrepreneurial spirit, a lack ofcoherent industry policies, the existing state-bureaucracy (fragmented funding as well asproblems to get permissions to establish and run a company), a lack of a supportiveindustrial "back-up area". The availability of venture capital is an issue which is discussedcontroversially in the literature and also by the Austrian actors. Whereas some researchmentions a lack of venture capital for biopharmaceutical sectors, funding organizations nolonger perceive lack of venture capital as a major problem.

5.2.2 Agro-Food Sector

(1) Main characteristics of the sector

Joining the EU in 1994 has had a serious impact on the agrarian and food sector. Hardly anyother sector in the economy has been affected as deeply as this one by the EU entry. TheAustrian agricultural and food sector stands out for some specific characteristics: Austria’sEU membership since 1994 had a grave impact on the agricultural and food sector. TheAustrian agriculture stands out for its "microscopic" structure (mainly small familiy runenterprises) and is a pioneer in organic farming. The seed-grain sector is dominated byforeign multinational seed-production companies in comparison to which the role played byAustrian companies is very small. The food processing industry also operates on a relativelysmall scale, with mainly small or medium sized companies. The Austrian food retailing


industry shows a very high level of concentration and the process of concentration is stilllasting.

(2) Leading forces of the whole sector

The Austrian food retailing industry can be identified as a leading force in the agricultural andfood sector. The retailing industry has the so called "market power". The concentrationtendencies within the retailing industry turned the market of supply into a market of demand,where the retailers dominate and define the product line. Another leading force of the sectoris the image of the Austrian agriculture to be the pioneer in organic farming. “Organic“farming products are currently offered by all major food retailing chains.

(3) Leading forces for biotech part of the sector

The lack of public acceptance of bio- and gene technological applications in the agriculturaland food production, the pressure of the relevant NGOs as well as the support of the tabloidpress of the averse public climate can be identified as the leading forces for the biotech partof the agricultural and food sector. Another important leading force are political decisions thatmore or less go inline with the public rejection of gene technological applications inagriculture and food processing.

(4) Inhibiting forces for biotech part of the sector

Summed up, the main barriers to the development of bio-/gene technology in the agriculturaland food sector lie in the fact that in both the research and the industry a so called "criticalmass" is missing, which is why there is no greater extent of innovation. In the researchsector, some research organisations are able to bring forth some qualitative excellent workon a relatively high international standard, compared to the means they can dispose of. Also,there are some single successful initiatives. Because of the small number of researchinstitutes and also because of the heterogeneity of the fields they do research on, theformation of a "critical mass" did not take place and therefore a process of building"innovation-chains" that would go beyond mere research activities was never achieved.Similar results can be obtained for the economic and industrial sector. Here we have ahandful of companies which stand out for working on very different fields. Furthermore, thereis a number of companies – mainly multinational ones – which are not working in the area ofbio-/gene technology in agriculture and food because of the averse public climate, althoughthey show ambitions on this field or used to until a few years ago. Since a so-called "criticalmass" is missing within the Austrian representatives of bio-/gene technology in theagricultural and food sector (research and industry), their influence on the policy of thecountry is not significant. Therefore, the orientation of political decisions has not been veryfavourable to promoting the research and development of this area of the biotechnologicalsector. The political decisions are characterised by ambivalence and have been made morein favour of the public scepticism against the bio-/gene technological applications inagriculture and food processing. A similar interpretation of the dynamics of the three poles of


public attitudes, the political decisions and the interests of the representatives ofbiotechnology was reached by Wagner et al. (1998) in their politico-scientific analyses.

5.2.3 Equipment and Supplies Sector

The Austrian equipment and supply sector is very small. Between 1994 and 1998, our surveyshowed that no funding organization had a special programme. Funding within the regularinstruments, however, might be included in the activities of the FFF, which cannot be brokendown by the three sectors. Given that estimated 90% of its funding is dedicated to thebiopharmaceutical sector, FFF funding for equipment and supply can be considered rathermodest. This result is in contrast with the results of Reiss (1999) (cf. also Table 34), whoreports considerable amounts for the sectors B4 and B7, which could be attributed to thissector. Our surveys, however, showed only little activity on the research as well as on theindustry side: Only one research institute and four companies reported that they were activein this sector. We therefore would conclude that little money of sectors B4 and B7 wasactually dedicated to the equipment and supply sector and must be attributed to othersectors, e.g. to the agro-food and to the biopharmaceutical sector.

The survey on research organisations showed little PSR activity in this sector. Only onepublic research institute reported among its activities in biopharmaceuticals, agro-food andenvironment research that it is active in this sector. In our survey, six responding companiesreported that they were active in the equipment and supplies sector. However, only four ofthem gave more detailed information about the company and their activities. The companiesare mainly small and medium sized - only one of them employs 400 people worldwide. Mostof the companies are export oriented, only the domestic branch of one company is orientedtowards Austria as its main market.

The main reason for the small number of Austrian companies, given by one of the experts, isthe rather limited Austrian market of biotechnology. Therefore, Austrian companies dependvery strongly on exports. Regarding laboratory equipment, experts agree that mostequipment is imported and that Austrian companies of this sub-sector are primarily tradingcompanies.

Whereas university expert saw little prospects for the sector because of the lack of industrial"back-up area" and public funding, a company representative was less pessimistic andassumed reasonable growth, this due to current governmental and municipal initiatives topromote biotechnology start-ups.

One promoting factor, stressed clearly by an expert from the industry, lies in internationallycompetitive PSR. Positive factors, indicated by an expert from the university, lie innetworking activities with foreign companies and R&D institutions and other initiatives likestart-ups from the university as well as the funding organisations like the FFF and FWF.

Experts from the universities indicated the following hampering factors: opposition of NGOsin the agro-food sector, a prevailing attitude in government of postponing decisions, lack of


venture capital, lack of determined, adequate and continuous funds, and, finally, the difficultposition of the sector given traditional funding guidelines, i.e. a type of research which isneither basic nor applied. Due to this peculiar in-between situation, funding from FWF (basicresearch) or from private companies (application orientated) is mostly prohibited.

5.3 Main Similarities and Differences

Due to the significant differences in size between the three biotechnology segments inAustria it is hardly surprising that very few elements can be named which are common for allthree sectors. In general, the similarities are mainly concentrated in the area of constraintsand inhibiting factors.

First, one finds an overall low public acceptance of biotechnology in general, headed by afierce opposition in the domain of agro-food and followed by a medium acceptance only inthe biopharmaceutical sector.

Second, one can see a relatively weak developed national "culture" of innovations, whichcan be found, on the one hand, in a wide-spread public "scepticism" against newtechnological developments or, on the other hand, in highly fragmented public innovationpolicies which only at a rather late stage of biotechnological development started to build upprogrammes specifically designed for biotechnology.

With respect to significant differences, the three segments of biotechnology exhibit anastonishing variety in size, in their linkages to the science base, in their embeddedness withnational and international companies or in their connections with public funding programmesboth at the regional, national and at the international level. Biotechnology in Austria isheaded by a dominant or leading sector in the field of biopharmaceutical products, followedby an agro-food segment which is fairly well integrated with the national science base, butwith a weak industrial structure only. Moreover, the agro-food sector in Austria is confrontedwith a weak public and political support or, more adequately, with a strong opposition by thepublic in general and by Public Interest-NGOs.

The third biotechnological segment is hardly recognizable as a sector of its own and isalmost entirely substituted via import linkages from abroad.

Given the present dimensions and development potentials, biotechnology in Austria is hardlyin a position to play the role of a "leading sector" or of a major "innovation pole" in theforeseeable future. At the present time, the number of start-up companies, the size of theagro-food sector and, above all, of the equipment and supply-segment follow along aninnovation and growth trajectory which is far away from the points and regions of a "criticalmass" necessary for the evolution of "leading sectors" or national "innovation poles".


5.4 Theoretical Conclusions

The starting point for the final part lies in a short summary of the relevant theoreticalassumptions, underlying four different approaches to industrial innovation. Table 35summarizes major ingredients of four perspectives for the analysis of technologicaldevelopment, namely (1) of "National Systems of Innovation", (2) of "TechnologicalSystems", (3) of "Socio-Technical Networks" and (4) of "Controversy Formation".

Table 36 gives an overall assessment of major findings of the Austrian case study and theirrelevance for the four theoretical approaches. Here, four groups of results can be reported.

Not surprisingly, the survey resulted in no findings which would be strongly inconsistent withone of the four perspectives. The main reason for the lack of strong inconsistencies lies inthe fact that all four perspectives are mainly "description devices" for the study oftechnological development and do not fulfill the criterion of well-formalized or axiomatizedtheories.

However, a large number of weakly inconsistent results can be reported between theAustrian findings and the NSI-approach. The main reason for these weak inconsistencieslies in the macro-orientation of the NSI-perspective. Here, a strong heterogeneity within atechnological sector as well as inconsistent technology and innovation policies within thesame technological field are difficult phenomena to cope with. Hence, the notion of “weakinconsistency" and "weak level inconsistency" have been introduced for the NSI-case.

Likewise, the surprisingly controversial formation of controversy formations within the sametechnological field and within similar segments (food-supply and health) must be consideredas a weak inconsistency for the fourth approach, since the basic distinctions forcontroversies do not follow along the line of "civilian/military utilization" or other controversialutilizations. Rather, the separation of controversies – weakly supportive for thebiopharmaceutical sector, strongly hostile for the agro-food sector – runs within two vitaldomains for human and societal maintenance, namely between food supplies and health.

In all other instances, the notions of "weak consistence" and "consistence" have beenemployed. The former concept has been used whenever an empirical result has norecognizable negative impact on a specific theoretical perspective, even though one doesnot find a direct support within the theoretical perspective under consideration.


6 Appendix

Appendix 1: Tables


Table 2: Public Attitudes Towards Bio-/Gene Technology. Comparison Austriaand European Union 1996

Responses to the question: "I`m going to read out a list of areas in which new technologies are currently

developing. For each of these areas, do you think it will improve our way of life in the next 20 years, it will have

no effect, or it will make things worse?" (Eurobarometer code Q6)

Country Will improve (%) No effect (%) Will make things worse (%) Don`t know (%)

Solar energy

Austria 71.9 16.6 1.1 10.4

EU 15 74.2 13.6 4 8.2

Computers and information technology

Austria 67.1 13.1 8.5 11.3

EU 15 76.1 8.1 8.6 7.2

Biotechnology and genetic engineering (mean over split ballot)

Austria 27.9 12.9 36.5 22.6

EU 15 44.3 9.2 21.6 24.9

Telecommunications

Austria 62 18.8 6.3 12.9

EU 15 80.6 9.6 3.7 6.1

New materials or substances

Austria 45.6 20.7 11.1 22.5

EU 15 64.5 12 6.3 17.2

Space exploration

Austria 44.2 29.8 9.2 16.7

EU 15 48.6 28.2 8.3 14.9

Split ballot: A: biotechnology

Austria 36.8 11.6 27.7 23.9

EU 15 50.1 8.4 15.1 26.4

Split ballot: B: genetic engineering

Austria 17.7 14.4 46.8 21.1

EU 15 39.4 9.7 26.8 24.2

Mean values of "image scale" (sum of items 2b, 2d and 2h. Scale 0-3, where 3 = high menacing images) and

"trend knowledge scale" (sum of items 2a, 2c, 2e, 2f and 2g. Scale 0-5, where 5 = high knowledge)

Country Image scale Trend knowledge scale

Austria 1.25 2.71

EU 15 0.88 3.08

Means for six applications of modern biotechnology according to perceived usefulness, risk, moral acceptability,

and whether they should be encouraged. (Eurobarometer code Q 10) (scale: -2 = low, to +2 = high)

Country Food production Crop plants Medicines & vaccines Research animals Xeno transplants Genetic testing

Usefulness

Austria -0.42 -0.23 0.61 -0.17 -0.36 0.38

EU 15 0.14 0.64 1.1 0.34 0.12 1.16

Risk

Austria 0.4 0.3 -0.04 0.06 0.17 -0.07

EU 15 0.46 0.15 0.05 0.24 0.49 -0.16

Moral acceptability

Austria -0.54 -0.43 0.2 -0.43 -0.53 0.15

EU 15 0.05 0.41 0.74 -0.19 -0.37 0.81


Whether they should be encouraged

Austria -0.83 -0.64 0.14 -0.46 -0.56 0.16

EU 15 -0.15 0.28 0.77 -0.1 -0.27 0.85

Mean values summed over the six applications (scale: -12 = low, +12 = high)

Country Useful Risky Acceptable Encouraged

Austria -0.18 0.82 -1.57 -2.2

EU 15 3.5 1.23 1.44 1.37

Responses to the question: "Before today, had you ever talked about modern biotechnology with someone?"

(Eurobarometer code Q17)

Country No (%) Yes (%)

Austria 20.6 79.4

EU 15 33.7 66.3

Means for responses to the questions: "Have you heard about or talked about biotechnology with someone?"

(Eurobarometer code Q16 and Q17)

Country No, never (%) Yes, frequently (%)Yes, occasionally (%)Yes, once or twice (%) Don't know (%)

Austria 38.9 14.4 24.7 15.0 7.0

EU 15 49.1 6.6 27.0 15.5 1.8

Source: Durant et al.1998, Appendix 2: selected results of Eurobarometer 46.1 1996; EU: total n=16246; Austria: n=1009.

Table 3: Biotechnological Research Areas of Relevant Research Institutes in theAgro-Food Sector

Research Organisation Research Area

Institute University basicbio

pharm.agrofood

equip.sup

environmronm.

other

Institut für Angewandte Mikrobiologie IAM BOKU ü ü ü ü ü

Zentrum für Angewandte Genetik ZAG BOKU ü ü ü

Institut für Lebensmitteltechnologie ILMT BOKU ü ü ü

Institut für Chemie BOKU ü ü ü

Institut für Tierzucht und Genetik VetMed ü ü ü ü

Institut für Mikrobiologie und Genetik Uni Wien ü ü ü ü ü ü

Institut für Biochemische Technologie undMikrobiologie TU Wien ü ü ü ü ü

Institut für Biotechnologie TU Graz ü ü ü ü ü ü

Institut für Biochemie und Lebensmittelchemie TU Graz ü ü ü

Institut für Analytische Chemie undRadiochemie

UniInnsbruck

ü ü ü

Institut für Allgemeine und ExperimentellePathologie

UniInnsbruck

ü ü ü

Inter- or Non-universitary research institutes

Interuniversitäres Forschungsinstitut fürAgrarbiotechnologie, IFA Tulln

ü ü ü ü

Forschungszentrum Seibersdorf, Lebenswissenschaften/Biotechnologie

ü ü ü ü ü

Institut für Molekularbiologie der Österreichischen Akademieder Wissenschaften ü ü ü

Sources: BKA/BMFV 1997; ÖGBT 1999; IHS-Survey 1999/2000 1999


Table 4: Number of Researchers in 1998 in Relevant Research Institutes in theAgro-Food Sector (Full Time Equivalent)

Research Organisation Total Agro-

Institute University Food

Institut für Angewandte Mikrobiologie IAM BOKU 120 24

Zentrum für Angewandte Genetik ZAG BOKU - -

Institut für Lebensmitteltechnologie ILMT BOKU - -

Institut für Chemie BOKU 3 0

Institut für Tierzucht und Genetik VetMed 37 10

Institut für Mikrobiologie und Genetik Uni Wien 60 25

Institut für Biochemische Technologie und Mikrobiologie TU Wien 466 52

Institut für Biotechnologie TU Graz 11 0

Institut für Biochemie und Lebensmittelchemie TU Graz 1.5 1.5

Institut für Analytische Chemie und Radiochemie Uni Innsbruck 9 1

Institut für Allgemeine und Experimentelle Pathologie Uni Innsbruck 17 5

Inter- or Non-universitary research institutes

Interuniversitäres Forschungsinstitut für Agrarbiotechnologie, IFA Tulln 70 -

Forschungszentrum Seibersdorf, Lebenswissenschaften/ Biotechnologie 15 3

Institut für Molekularbiologie der Österreichischen Akademie der Wissenschaften 48* -

Total Number 857.5 121.5

Source: IHS-Survey 1999/2000 1999; * Internetrecherche; “-“ … no answer/not available

Table 5: Number of Masters (First-University absolvents) and PhDs (Second-University Absolvents) 1994-1998 at Relevant University Institutes in theAgro-Food Sector

Research Organisation Masters Masters PhDs PhDs

Institute University TotalAgro-Food

TotalAgro-Food

Institut für Angewandte Mikrobiologie IAM BOKU 100 20 87 19

Zentrum für Angewandte Genetik ZAG BOKU - - - -

Institut für Lebensmitteltechnologie ILMT BOKU - - - -

Institut für Chemie BOKU - - - -

Institut für Tierzucht und Genetik49 VetMed 0 0 31 20

Institut für Mikrobiologie und Genetik Uni Wien

Institut für Biochemische Technologie und Mikrobiologie TU Wien 8 0 6 1

Institut für Biotechnologie TU Graz - - - -

Institut für Biochemie und Lebensmittelchemie TU Graz - - - -

Institut für Analytische Chemie und Radiochemie Uni Innsbruck 6 1 4 0

Institut für Allgemeine und Experimentelle Pathologie Uni Innsbruck 7 0 19 0

Total Number 121 21 147 40

Source: IHS-Survey 1999/2000 1999; “-“ … no answer

49 Neuberufung seit 1993. Keine ErstabsolventInnen. Zweitabsolventinnen seit 1995.


Table 6: Austrian Agricultural Structure 1997

Agricultural holdings grouped by size of agricultural land Number in Percent

no agricultural land 1881 0.7

less than 5 ha 84611 33.6

5 to less than 10 ha 41922 16.6

10 to less than 20 ha 46805 18.6

20 to less than 30 ha 30231 12.0

30 to less than 50 ha 27061 10.7

50 to less than 100 ha 12693 5.0

100 to less than 200 ha 3691 1.5

more than 200 ha 3215 1.3

Total 252110 100.0

Source: BMLF 1999: 60, based on Agrarstukturerhebung 1997

Table 7: Number of Agricultural Holdings in Austria 1951-1997

1951 1960 1970 1980 1990 1995 1997

432.848 402.286 342.169 318.085 281.910 263.522 252.110

Source: BMLF 1999: 196, based on ÖSTAT

Table 8: Agricultural Structure of EU-Member States 1995

EU member stateaverage size of agricultural holding

(ha per holding)

number of agricultural holdings

(in 1000 holdings)

Austria 15.4 221.8

Belgium 19.1 71

Denmark 39.6 68.8

Finland 21.7 101

France 38.5 734.8

GB 70.1 234.5

Germany 30.3 566.9

Greece 4.5 802.4

Ireland 28.2 153.4

Italy 5.9 2482.1

Luxembourg 39.9 3.2

Netherlands 17.7 113.2

Portugal 8.7 450.6

Spain 19.7 1277.6

Sweden 34.4 88.8

EU-15 ∅ 17.4 491.3

Source: BMLF 1999: 69, based on data (“Agrarstrukturerhebung”) of the EU 1995


Table 9: Share of Organic Farming in EU-Member States 1995 andSwitzerland 1996

Country % of agricultural land % of agricultural holding

Austria 6.51 7.34

Belgium 0.19 0.25

Denmark 1.42 1.55

Finland 1.94 2.52

France 0.28 0.45

GB 0.28 0.34

Germany 1.80 1.10

Greece 0.04 0.08

Ireland 0.28 0.27

Italy 1.17 0.41

Luxembourg 0.49 0.62

Netherlands 0.58 0.5

Portugal 0.28 0.07

Spain 0.09 0.07

Sweden 2.22 2.68

Switzerland* 1.58 4.62

Source: BMLF/Culinar et al. 1997; 194-196, based on Lampkin 1996

Table 10: Number of Organic Farms in Austria 1970-1998*

1970 1972 1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998**

25 30 40 55 100 200 320 420 600 880 1539 6000 13321 19878 20100

* Farms that switch to organic farming are included. ** Estimated value (cf. BMLF 1999: 209)Source: BMLF/Culinar et al. 1997: 32, calculations, based on ARGE Biolandbau

Table 11: Subsidies for Organic Farming in Austria

Year Mio ATS Mio EURO

1990 5.9 0.429

1991 26.4 1.919

1992 175.6 12.761

1993 170.6 12.398

1994 234.9 17.071

1995 725.3 52.710

1996 831.8 60.449

1997 869.9 63.218

1998* 893.9 64.962

* Estimated value (cf.BMLF 1999: 209).Source: BMLF 1999: 209, based on data of BKA, AMA, ARGE Bio-Landbau


Table 12: Industry Statistic for the Food Processing Industry and Trade in Austria*

Statistics for food processing industry and trade 1995 1996 1997

Food processing industry and trade

number of companies 1245 1209 1151

production value of a year in Mio ATS 118121 113840 113953

number of employees 60544 58171 55661

∅ number of employees per company 48.6 48.1 48.4

Food processing industry





Food processing industry and trade





* Companies with 10 and more employees are included.Source: WKÖ 1996/97, based on ÖSTAT and WKÖ

Table 13: Development of the Food Processing Industry 1980-1995*

Statistics for food processing industry 1980 1985 1990 1993 1994 1995

number of companies 605 591 553 502 489 451

production value of a year in Mio ATS 53794 70730 79390 87595 88456 82677

number of employees 49795 44921 42973 40005 38963 35833

∅ number of employees per company 82.3 76.0 77.7 79.7 79.7 79.5

* Production and processing of tea, coffee, alcoholic drinks, etc. is included, production and processing oftobacco is excluded.

Source: WKÖ 1995: 100, 102, 104, based on ÖSTAT and WKÖ; WKÖ 1995, 100, 102, 104

Table 14: The 20 Largest Food Processing Companies in Europa 1996

Rank Company CountryTurnover in

Mio Euro

Number of

employees

1 Unilever NL/GB 40011.15 306000

2 Nestlé CH 37512.97 221100

3 Compart (Ferruzzi Fin) I 12749.57 35400

4 Danone (BSN) F 12606.92 81600

5 Grand Metropolitan GB 11194.74 66000

6 Eridania/Beghin-Say F 8257.36 19400

7 Kraft Jacobs Suchard CH 7173.43 30800

8 Allied-Domecq GB 6451.99 71800

9 Tate & Lyle GB 6199.93 13800


10 Cadbury Schweppes GB 6145.73 42900

11 Bass GB 6138.57 76200

12 Philip Morris D 5883.44 3600

13 Heineken NL 5552.63 31600

14 Dalgety GB 5209.04 14500

15 Tabacalera E 4955.95 7300

16 Sara Lee/DE NL 4328.60 21700

17 Coca-Cola Dtld. D 3993.19 14000

18 Besnier F 3920.07 13500

19 Südzucker D 3884.80 19200

20 Hillsdown Holdings GB 3855.65 31000

Source: Weindlmaier 1999: 41, based on Creditforum

Table 15: The 20 Largest Food Processing Companies in Austria 1998/99

Rank CompanyTurnover inMrd. ATS

Turnover inMio EURO

Number ofemployees

1 Brau Union AG (1997) 9.49 689.67 4569

2 Österreichische Unilever GmbH 6.70 486.91 -

3 Berglandmilch reg.GenmbH 7.07 513.80 950

4 Agrana Zucker GmbH 4.98 361.91 770

5 Master Foods Austria GmbH 4.25 308.86 700

6 Kraft Jacobs Suchartd Österreich GmbH 3.99 289.96 160

7 NÖM AG 2.88 209.30 -

8 Unifrost GmbH 2.75 199.85 650

9 Spitz GmbH 2.40 174.41 495

10 Rauch Fruchtsäfte GmbH 2.30 167.15 230

11 Ankerbrot AG 2.27 164.97 2500

12 Red Bull GmbH 2.20 159.88 61

13 Nestlé Österreich GmbH 1.78 129.36 475

14 Triol Milch reg. Gen.mbH 1.40 101.74 280

15 C.H. Knorr Nahrungsmittel GmbH 1.27 92.29 363

16 Josef Manner & Comp. AG 1.20 87.21 697

17 Rudolf ÖLZ Meisterbäcker GmbH 1.05 76.31 540

18 Kelly GmbH 1.01 73.40 450

19 Alpenmilch Salzburg reg.Gen.mbH 1.00 72.67 162

20 Hermann Pfanner GmbH 1.00 72.67 180

Source: Weindlmaier 1999: 41, based on Creditforum


Table 16: Share of Food Retailing Chain on the Total Turnover of the FoodRetailing Industry in Austria

Share of Total Turnover in Food Retailing in % 1995 1996 1997 1998

BML 24.7 30.1 32.5 32.8

Spar 21.9 26.2 27.1 27.2

ZEV Markant 22.4 18.6 16.7 16.3

Löwa 5.5 5.1 5.4

Adeg 12.0 12.8

Konsum 12.4

restliche Filialisten u. überiger LH (ab 1997 inkl Adeg) 6.6 6.8 18.6 18.3

Total Turnover in Food Retailing in % 100.0 100.0 100.0 100.0

Total Turnover in Food Retailing in Mio ATS 143222 143465 146035 148543

Source: AC Nielsen 1999

Table 17: Share of Food Retailing Chain on the Total Number of Food Stores inAustria

Share of Total Number in Food Stores in % 1995 1996 1997 1998

BML 12.0 13.0 14.4 15.1

Spar 20.5 21.2 21.3 21.4

ZEV Markant 27.7 22.9 23.4 23.5

Löwa - - 3.7 3.9

Adeg 17.8 17.9 - -

Konsum - - - -

restliche Filialisten u. überiger LH (ab 1997 inkl Adeg) 22.0 21.1 37.2 36.1

Total Number of Food Stores in % 100.0 100.0 100.0 100.0

Share of Total Number of Food Stores 7941 7618 7337 7166

Source: AC Nielsen 1999


Table 18: Main Characteristics of Biotech Firms in the Agro-Food Sector

Company Biopharma Agro-Food Equipment & Supplies

A - ü -

B - ü -

C - ü -

D ü ü -

Total 1 4 -

Company No. of employees year foundedBiotech turnover

(% of totalturnover)

Biotech turnoveragro-food

(% of total turnover)

A 1-20 1989 100 100

B 21-50 1986 100 100

C 101-500 1948 n.a. n.a.

D 500+ 1946 100 < 10

Company subsidiary universityspin-off

companyspin-off

independentlyestablished

merger

A ü - - ü -

B ü - - - -

C - - - ü -

D ü - - ü -

Total 3 - - 3 -

Company

Specific Technologies used by company A B C D Total

Cell culture - - - - 1

Gene transfer - - - - -

Molecular synthesis - - - - -

Separation technology - - - - 1

Gene technology - - - - -

Recombinant DNA - - - - -

Monoclonal antibodies - - - - -

Hormones and growth factors - - - ü 1

Micropropagation/tissue culture - - - - -

Protein engineering - - - - -

Genomics and gene function - - - - -

Gene amplication/PCR - - - - -

Bioprocessing (bioreactors, fermentation tech.) ü ü ü - 3

CompanySelling biotech

productsOfferingservices

Productresearch

Productdevelopment

Technologydevelopment

A ü - ü ü üB - ü ü ü üC ü - ü ü üD ü - - - -

Total 3 1 3 3 3

Company national patents EU patents US patents world patents

A 1 - - -

B 4 4 - -

C n.a. n.a. n.a. n.a.

D - - - -

Total 5 4 - -


Conducting No. of trials and location where trials taking place

Company trials domestic European US in other countries

A ü 1 1 - -

B - - - - -

C n.a. - - - -

- - - - -

Total 1 1 1 - -

Conducting trials undertaken with partner

Company trials domestic trials European trials US trials in other countries

A ü - - - -

B - - - - -

C n.a. n.a. n.a. n.a. n.a.

D - - - - -

Total 1 - - - -

Company subsidiary location ofparent

universityspin-off

companyspin-off

independentlyestablished

merger

A ü Germany - - ü -

B ü Austria - - - -

C - - - - ü -

D ü CH - - ü -

Total 3 - - 3 -

Companytotal turnover

Mio Euro

BT turnoveragro-food

(% of total)

sellingbiotech

products

turnoverproductsMio Euro

offeringservice

turnoverservicesMio Euro

licensingincome

A 0.750 100 ü 0.750 - - -

B 2.907 100 - - ü 2.907 -

C 167.151 - ü 167.151 - - -

D 650.000 < 10 ü 65.000 - - -

Total 235.808 3 232.901 1 2.907 -

CompanyMarket of

products / services main market1 main market2 main market3 main market4

A selling biotech products domestic Europe - -

B offering services Europe domestic World-wide -

C selling biotech products World-wide - - -

D selling biotech products US Mid-America Far East -

Company R&D collaborations No of collaborations and nationality of partner:

with PSR domestic European US other country

A ü 2 - - -

B ü - 1 - -


D - - - - -

Total 2 2 1 - -

Company R&D collaborations No of collaborations and nationality of partner:

with other companies domestic European US any other country

A ü - 1 - -

B ü - 2 - -


D - - - - -

Total 2 - 3 - -

Source:IHS-Survey 1999/2000, 1999 n. a. … not available


Table 19: Deliberate Releases of GMOs in the EU 1992-2000

Country Total number of summary notifications circulated January 10th, 2000

Austria 3Belgium 99Denmark 39Finland 16France 459Germany 102Greece 19Ireland 4Italy 258Netherlands 117Portugal 12Spain 166Sweden 54United Kingdom 184

Total for the European Union 1532

Source: List of SNIFs (Summary Notification and Information Format) circulated under Article 9 of Directive90/220/EEC from October 21st, 1991 to January 10th, 2000 (cf. SNIFS).The competent authorities of the MemberStates of the EU send to the European Commission (Joint Research Centre – Ispra) a summary of each notificationreceived.


Appendix 2: Forms of Direct Democracy in Austria

In Austria, forms of direct democracy are comparably weak (cf. Funk 1996). The AustrianFederal Constitution contains three forms of a direct democracy (Federal Constitution Act –Bundes-Verfassungsgesetz – B-VG). (1) the "popular initiative" – Volksbegehren (Art 41 Abs2 B-VG), (2) the "referendum" – Volksabstimmung (Art 43 und 44 B-VG), (3) the "opinionpoll" – Volksbefragung (Art 49b B-VG). The first two instruments exist since 1920, and theinstrument of the opinion poll was introduced in 1988.

There are principally two different kinds of referendum: Whenever the Federal Parliamentdecrees, or the majority of its members demands that a legal resolution by the FederalParliament be subject to a referendum, this is called a "facultative" referendum (Art 43 B-VG). An overall change of the Federal Constitution, however, has to be subject to the vote ofthe entire population – this is called an "obligatory" referendum (Art 44 para. 3 B-VG). Theprocedure of the referendum corresponds to that of a secret vote. People are asked whethera resolution by the Federal Parliament should pass into law or whether the FederalConstitution should be changed. The Federal Parliament has to act according to theoutcome of the referendum (Referendum Act – Volksabstimmungsgesetz 1972) (cf. Funk1996; BMI 1999) .

In the history of Austria, two topics have already been subject to a referendum:

(1) Referendum on the Federal Act on thePeaceful Use of Nuclear Energy in Austria(opening of the nuclear power plantZwentendorf), November 5th, 1978. This was aso-called facultative referendum. 3 183 486 validvotes were cast during the course of thisreferendum (62.62% of the people eligible tovote). 50.5% of the Austrians voted "no" and49.5% voted "yes".

(2) Referendum to find out whether Austria shouldjoin the European Union. June 12, 1994. Since themembership of Austria in the European Unionresulted in an overall change of the Austrian FederalConstitution this had to be a so-called "obligatory"referendum. 4 724 831 valid votes were cast duringthe course of this referendum (81.16% of the peopleeligible to vote). 66.6% of the Austrians voted "yes"and 33.4 % voted "no".

An opinion poll may be carried out if the question within the context of the Federal legislationis fundamental or affects the entire country (Art 49b B-VG). The procedure of an opinion pollcorresponds to that of a secret vote. The Federal Parliament does not necessarily have toact according to the outcome of the opinion poll. Until the end of 1999, no opinion polls havebeen carried out on a national level (cf. Funk 1996, BMI 1999).

The popular initiative presents the right to take initiatives (legal proposals or bills) with noobligations for the Federal Parliament. The legislative procedure in the Federal Parliamentstarts with a legal proposal. Legal initiatives may be presented by the members of theFederal Parliament, by the Federal Council (Bundesrat), by the Federal Government, or bythe Austrian population. (Art 41 para. 1 B-VG). Legal proposals by the Austrian population(Popular Initiative Act, Art 41 para. 2 B-VG) may be only be presented if they are supportedby at least 100 000 people who are eligible to vote or by a sixth of the eligible voters of threeRegional Provinces (Bundesländer). The content has to refer to affairs of the Federal


legislation. The text of the popular initiative may be worded in the form of a bill or a proposal(§ 3 Art. 3 Popular Initiative Act 1973) (cf. Funk 1996; BMI 1999).

Until December 1999, a total of 24 popular initiatives have been carried out in Austria. 20 of thoseinitiatives took place in the period between 1980 and 1999. It should be pointed out though, that theinitiatives during that period were mainly used by opposition parties, especially by the Freedom Party(FPÖ), as an instrument to bring in legal proposals. The popular initiative on gene technology, which wassigned by 1.23 million people during the period from April 7th to April 14th, 1997, was the second mostsuccessful initiative in the history of Austria – that corresponds to a participation of 21.23% of the peopleeligible to vote at that time.

Popular initiatives in Austria 1964-1999 Number

1960-1969 3

1970-1979 1

1980-1989 10

1990-1999 10

Total number of popular initiatives 24

Source: Federal Electoral Authority (Österreichische Bundeswahlbehörde): Results of popular initiatives(as of December 6th, 1999)


Appendix 3: Regulatory Framework for Bio-/Gene technology

Austrian Gene Technology Act – GTG: Ordinances to Put the GTG in Concret Terms

Ordinances of the GTG ResponsibleAuthorities 1995 – 1997

ResponsibleAuthorities1997 – 04 2000

Systemverordnung: Verordnung des Bundesministers fürGesundheit und Konsumentenschutz über die Sicherheit beiArbeiten mit gentechnisch veränderten Organismen ingeschlossenen Systemen (VO Nr. 116/1996, ausgegeben am 8.März 1996)

BMGSK on goodterms with BMwA,BMAS, BMLF,BMUJF, BMWFK

BKA/BMFV ongood terms withBMwA, BMAGS,BMLF, BMUJF,BMWV

Freisetzungsverordnung: Verordnung des Bundesministers fürGesundheit und Konsumentenschutz über Inhalt, Umfang undForm des Antrages auf Genehmigung einer Freisetzunggentechnisch veränderter Organismen (VO Nr. 49/1997,ausgegeben am 14. Februar 1997 Teil II)

BMGSK on goodterms with BMLF,BMUJF, BMwA,BMWFK.

BKA/BMFV ongood terms withBMLF, BMUJF,BMwA, BMWV.

Anhörungsverordnung: Verordnung des Bundesministers fürGesundheit und Konsumentenschutz über dasAnhörungsverfahren gemäß dem Gentechnikgesetz(Anhörungsverordnung) (VO Nr. 61/1997, ausgegebenen am28. Februar 1997 Teil II)

BMGSK on goodterms withBMWFK andBMwA.

BKA/BMFV ongood terms withBMWV andBMwA.

Änderung der Anhörungsverordnung: Verordnung desBundesministerin für Frauenangelegenheiten undVerbraucherschutz, mit der die Anhörungsverordnung geändertwird (VO Nr. 164/1998, ausgegeben am 13. Mai 1998 Teil II)

BKA/BMFV ongood terms withBMWV andBMwA.

Gentechnik-Kennzeichnungsverordnung: Verordnung derBundesministerin für Frauenangelegenheiten undVerbraucherschutz über die Kennzeichnung von Erzeugnissen,die aus gentechnisch veränderten Organismen bestehen odersolche enthalten, und über weitere Angaben zu derenInverkehrbringen (VO Nr. 59/1998, ausgegeben am 26. Februar1998 Teil II)

BKA/BMFV ongood terms withBMUJF, BMwAand BMWV.

Verbot des Inverkehrbringens von gentechnisch verändertemMais mit der kombinierten Veränderung der Insektizidwirkungdes BT-Endotoxin-Gens und erhöhter Toleranz gegenüber demHerbizid Glufosinatiammonium (VO Nr. 45/1997, ausgegebenam 13. Februar 1997 Teil II)

BMGSK BKA/BMFV

Verbot des Inverkehrbringens des gentechnisch verändertenMaises Zea mays L., Linie MON 810, in Österreich. Verordnungder Bundesministerin für Frauenangelegenheiten undVerbraucherschutz (VO Nr. 175/1999, ausgegeben am 10. Juni1999)

BKA/BMFV

Verbot des Inverkehrbringens des gentechnisch verändertenMaises Zea mays L. T25 in Österreich. Verordnung derBundesministerin für soziale Sicherheit und Generationen (VONr. 120/2000, ausgegeben am 28. April 2000)

BKA/BMFV

Saatgut-Gentechnik-Kennzeichnungsverordnung: Verordnungdes Bundesministers für Land- und Forstwirtschaft über dieKennzeichnung von gentechnisch veränderten Sorten undSaatgut gentechnisch veränderter Sorten. Verordnung derBundesministerin für Frauenangelegenheiten undVerbraucherschutz (VO 74/1999, ausgegeben am 11. März1999 Teil II)

BMLF


AEV Gentechnik: Verordnung des Bundesministers für Land-und Forstwirtschaft über die Begrenzung vonAbwasseremissionen aus Arbeiten mit genteschnischveränderten Organismen (VO Nr. 350/1997, ausgegeben am28. November 1997 Teil II)

BMLF on goodterms withBMwA undBMUJF

Verordnung biologische Arbeitsstoffe – VbA: Verordnung derBundesministerin für Arbeit, Gesundheit und Sozailes über denSchutz der Arbeiternehmer/innen gegen Gefährdung durchbiologische Arbeitsstoffe (VO Nr. 237/1998, ausgegebenen am23. Juli 1998 Teil II)

BMAGS

Gentechnikregister für die Erzeugnisse gemäß § 54 Abs. 1GTG

BKA/BMFV

Board of Biotechnology: Anforderungen an Veranlassung undDurchführung einer Genanalyse im Sinne des § 65 Abs 1 Z 1GTG und an eine Einrichtung gemäß § 68 GTG

Advisory Board onGene technology

Advisory Boardon Genetechnology

Report of the Advisory Board on Gene Technology Advisory Board onGene technology

Advisory Boardon Genetechnology

European Union: Regulatory Framework for Biotechnology

SystemrichtlinieRichtlinie 90/219/EWG: Richtlinie des Rates vom 23. April 1990 über die Anwendung genetisch

veränderter Mikroorganismen in geschlossenen Systemen (90/219/EWG)Entscheidung der Kommission vom 29. Juli 1991 betreffend die Leitlinie für die Einstufung gemäß Artikel 4

der Richtlinie 90/219/EWG des Rates (91/448/EWG)Richtlinie 94/51/EG der Kommission vom 7. November 1994 zur ersten Anpassung der Richtlinie

90/219/EWG über die Anwendung gentechnisch veränderter Mikroorganismen in geschlossenSystemen an den technischen Fortschritt

Entscheidung der Kommission vom 16. Januar 1996 zur Änderung der Entscheidung 91/448/EWGbetreffend die Leitlinien für die Einstufung gemäß Artikel 4 der Richtlinie 90/219/EWG des Rates überdie Anwendung genetisch veränderter Mirkroorganismen in geschlossenen Systemen (96/134/EG)

Richtlinie 98/81/EG des Rates vom 26. Oktober 1998 zur Änderung der Richtlinie 90/219/EWG über dieAnwendung gentechnisch veränderter Mikroorganismen in geschlossenen Systemen

FreisetzungsrichtlinieRichtlinie 90/220/EWG: Richtlinie des Rates vom 23. April 1990 über die absichtliche Freisetzung

genetisch verändeter Organismen in die UmweltEntscheidung der Kommission vom 21. Mai 1991 betreffend eine Liste der gemeinschaftlichen

Rechtsvorschriften gemäß Artikel 10 der Richtlinie 90/220/EWG (91/274/EWG)Entscheidung des Rates vom 4. November 1991 über den formalen Aufbau der Zusammenfassung der

Anmeldung nach Artikel 9 der Richtlinie 90/220/EWG über die absichtliche Freisetzung genetischveränderter Organismen in die Umwelt (91/596/EWG)

Entscheidung der Kommission vom 11. Februar 1992 betreffend den formalen Aufbau derZusammenfassung der Anmeldung gemäß Artikel 12 der Richtlinie 90/220/EWG)

Entscheidung der Kommission vom 22. Oktober 1993 zur Festlegung der Kriterien für vereinfachteVerfahren für die absichtliche Freisetzung genetisch verändeter Pflanzen gemäß Artikel 6 Absatz 5 derRichtlinie 90/220/EWG des Rates (93/584/EWG)

Entscheidung 94/211/EG: Entscheidung der Kommission vom 15. April 1994 zur Änderung derEntscheidung 91/596/EWG des Rates hinsichtlich der Zusammenfassung der Anmeldung nach Artikel 9der Richtlinie 90/220/EWG des Rates

Richtlinie 94/15/EG der Kommission vom 15. April 1994 zur ersten Anpassung der Richtlinie 90/220/EWGdes Rates über die absichtliche Freisetzung gentechnisch veränderter Organismen in die Umwelt anden technischen Fortschritt

Entscheidung der Kommission vom 4. November 1994 zur Festlegung von vereinfachten Verfahren für dieabsichtliche Freisetzung genetisch verändeter Pflanzen nach Artikel 6 Absatz 5 der Richtlinie90/220/EWG des Rates (94/730/EG)


Richtlinie 97/35/EG der Kommission vom 18. Juni 1997 zur zweiten Anpassung der Richtlinie90/220/EWG über die absichtliche Freisetzung gentechnisch veränderter Organismen in die Umwelt anden technischen Fortschritt

Neuartige Lebensmittel (einschließlich gentechnisch verändeter Lebensmittel)Richtlinie des Rates vom 18. Dezember 1978 zur Angleichung der Rechtsvorschriften der Mitgliedstaaten

über die Etikettierung und Aufmachung von für den Endverbraucher bestimmten Lebensmitteln sowiedie Werbung hierfür (79/112/EWG)

Verordnung (EG) Nr. 258/97 des Europäischen Parlaments und des Rates vom 27. Januar 1997 überneuartige Lebensmittel und neuartige Lebensmittelzutaten (Novel Food Verordnung)

Empfehlung der Kommission (97/618/EG) vom 29. Juli 1997 zu den wissenschaftlichen Aspekten und zurDarbietung der für Anträge auf Genehmigung des Inverkehrbringens neuartiger Lebensmittel undLebensmittelzutaten erforderlichen Informationen sowie zur Erstellung der Berichte über die Erstprüfunggemäß der Verordnung (EG) Nr. 258/97 des Europäischen Parlaments und des Rates

Verordnung (EG) Nr. 1139/98 des Rates vom 26. Mai 1998 über Angaben, die zusätzlich zu den in derRichtlinie 79/112/EWG aufgeführten Angaben auf der Etikettierung bestimmter aus genetischveränderten Organismen hergestellter Lebensmittel vorgeschrieben sind

Verordnung (EG) Nr. 49/2000 der Kommission vom 10. Januar 2000 zur Änderung der Verordnung (EG)Nr. 1139/98 des Rates über Angaben, die zusätzlich zu den in der Richtlinie 79/112/EWG aufgeführtenAngaben bei der Etikettierung bestimmter aus genetisch veränderten Organismen hergestellterLebensmittel vorgeschrieben sind

Verordnung (EG) Nr. 50/2000 der Kommission vom 10. Januar 2000 über die Etikettierung vonLebensmitteln und Lebensmittelzutaten, die genetisch veränderte oder aus genetisch verändertenOrganismen hergestellte Zusatzstoffe und Aromen enthalten

Richtlinie über den rechtlichen Schutz biotechnologischer ErfindungenRichtlinie 98/44/EG des Europäischen Parlaments und des Rates vom 6. Juli 1998 über den rechtlichen

Schutz biotechnologischer ErfindungenProduktzulassungen in der Europäischen Union93/572/EWG: Entscheidung der Kommission vom 19. Oktober 1993 über das Inverkehrbringen eines

GVO enthaltenden Produktes im Sinne von Artikel 13 der Richtlinie 90/220/EWG des RatesEntscheidung der Kommission vom 8. Juni 1994 über das Inverkehrbringen eines genetisch veränderte

Organismen enthaltenden Produkts – Samen der herbizidresistenten Tabaksorte ITB 1000 OX - nachArtikel 13 der Richtlinie 90/220/EWG des Rates

94/505/EG: Entscheidung der Kommission vom 18. Juli 1994 zur Änderung der Entscheidung vom 18.Dezember 1992 über das Inverkehrbringen eines GVO enthaltenden Produkts – Lebendimpfstoff Nobi-Porvac Aujeszky (gl, tk) – im Sinne von Artikel 13 der Richtlinie 90/220/EWG des Rates

Entscheidung der Kommission vom 6. Februar 1996 über das Inverkehrbringen eines genetischveränderte Organismen enthaltenden Produkts – herbizidresistente Rapshybride Samen (Brassicanapus L. oleifera Metzq. MS1Bn x RF1Bn) gemäß der Richtlinie 90/220/EWG des Rates

Entscheidung der Kommission vom 3. April 1996 über das Inverkehrbringen genetisch veränderterSojabohnen (Glycin max. L.) mit erhöhter Verträglichkeit des Herbizids Glyphosat nach der Richtlinie90/220/EWG des Rates.

Entscheidung der Kommission vom 20. Mai 1996 über das Inverkehrbringen genetisch verändertermännlich-steriler Chicoree-Pflanzen (Cichorium intybus L.) mit teilweiser Toleranz gegenüber demHerbizid Gulfosinatammonium gemäß der Richtlinie des Rates 90/220/EWG

Entscheidung der Kommission vom 23. Januar 1997 über das Inverkehrbringen von genetischverändertem Mais (Zea Mays L.) mit der kombinierten Veränderung der Insektizidwirkung des BT-Endotoxin-Gens und erhöhter Toleranz gegenüber dem Herbizid Gulfosinatammonium gemäß derRichtlinie 90/220/EWG des Rates

Entscheidung der Kommission vom 6. Juni 1997 über das Inverkehrbringen von genetisch verändertemRaps (Brassica napus L. oleifera Metzg. MS1, RF1) gemäß der Richtlinie 90/220/EWG des Rates

Entscheidung der Kommission vom 6. Juni 1997 über das Inverkehrbringen von genetisch verändertemRaps (Brassica napus L. oleifera Metzg. MS1, RF2) gemäß der Richtlinie 90/220/EWG des Rates

Entscheidung der Kommission vom 14. Juli 1997 über das Inverkehrbringen des T102-Tests(Streoptococcus thermophilus T102) gemäß der Richtlinie 90/220/EWG des Rates

Nationale Entscheidung der zuständigen Behörde der Niederlande vom 1. Dezember 1997 über dasInverkehrbringen von genetisch veränderten Nelken (Dianthus caryophyllus L.) gemäß der Richtlinie90/220/EWG des Rates


Entscheidung der Kommission vom 22. April 1998 über das Inverkehrbringen von genetisch verändertemMais (Zea mays L., Linie MON 810) gemäß der Richtlinie 90/220/EWG des Rates

Entscheidung der Kommission vom 22. April 1998 über das Inverkehrbringen von genetisch verändertemMais (Tea mays L. T25) gemäß der Richtlinie 90/220/EWG des Rates

Entscheidung der Kommission vom 22. April 1998 über das Inverkehrbringen von genetisch verändertemMais (Zea mays L., Liniw Bt-11) gemäß der Richtlinie 90/220/EWG des Rates

Entscheidung der Kommission vom 22. April 1998 über das Inverkehrbringen von genetisch verändertemSommerraps (Brassica napus L. ssp. oleifera) gemäß der Richtlinie 90/220/EWG des Rates

Nationale Entscheidung der zuständigen Behörde der Niederlande vom 20. Oktober 1998 über dasInverkehrbringen von genetisch veränderten Nelken (Dianthus caryophyllus L.) gemäß der Richtlinie90/220/EWG des Rates

Nationale Entscheidung der zuständigen Behörde der Niederlande vom 20. Oktober 1998 über dasInverkehrbringen von genetisch veränderten Nelken (Dianthus caryophyllus L.) gemäß der Richtlinie90/220/EWG des Rates

Richtlinie über den Schutz der Arbeitnehmer gegen Gefährdung durch biologische Arbeitsstoffe bei derArbeit

Richtlinie 90/679/EWG des Rates vom 26. November 1990 über den Schutz der Arbeitnehmer gegenGefährdung durch biologische Arbeitsstoffe bei der Arbeit (Siebte Einzelrichtlinie im Sinne von Artikel 16Absatz 1 der Richtlinie 89/391/EWG)

Richtlinie 93/88/EWG des Rates vom 12. Oktober 1993 zur Änderung der Richtlinie 90/679/EWG über denSchutz der Arbeitnehmer gegen Gefährdung durch biologische Arbeitsstoffe bei der Arbeit (SiebteEinzelrichtlinie im Sinne von Artikel 16 Absatz 1 der Richtlinie 89/391/EWG)

Richtlinie 95/30/EG der Kommission vom 30. Juni 1995 zur Anpassung der Richtlinie 90/679/EWG desRates über den Schutz der Arbeitnehmer gegen Gefährdung durch biologische Arbeitsstoffe bei derArbeit an den technischen Fortschritt (Siebte Einzelrichtlinie im Sinne von Artikel 16 Absatz 1 derRichtlinie 89/391/EWG)

Richtlinie 97/59/EG der Kommission vom 7. Oktober 1997 zur Anpassung der Richtlinie 90/679/EWG überden Schutz der Arbeitnehmer gegen Gefährdung durch biologische Arbeitsstoffe bei der Arbeit (SiebteEinzelrichtline im Sinne von Artikel 16 Absatz 1 der Richtlinie 89/391/EWG) an den technischenFortschritt

Richtlinie 97/65/EG der Kommission vom 26. November 1997 zur dritten Anpassung der Richtlinie90/679/EWG des Rates über den Schutz der Arbeitnehmer gegen Gefährdung durch biologischeArbeitsstoffe bei der Arbeit an den technischen Fortschritt

Weitere Rechtsakte der Europäischen Union betreffend biotechnologisch hergestellte ProdukteRichtlinie 87/21/EWG des Rates vom 22. Dezember 1986 zur Änderung der Richtlinie 65/65/EWG zur

Angleichung der Rechts- und Verwaltungsvorschriften über ArzneispezialitätenVerordnung (EWG) Nr. 2309/93 des Rates vom 22. Juli 1993 zur Festlegung von Gemeinschaftsverfahren

für die Genehmigung und Überwachung von Human- und Tierarzneimitteln und zur Schaffung einerEuropäischen Agentur für die Beurteilung von Arzneimitteln

Richtlinie 91/414/EWG des Rates vom 15. Juli 1991 über das Inverkehrbringen von PflanzenschutzmittelnRichtlinie 96/68/EG der Kommission vom 21. Oktober 1996 zur Änderung der Richtlinie 91/414/EWG des

Rates über das Inverkehrbringen von PflanzenschutzmittelnRichtlinie 97/57/EG des Rates vom 22. September 1997 zur Festlegung des Anhangs VI der Richtlinie

91/414/EWG über das Inverkehrbringen von PflanzenschutzmittelnRichtlinie 98/95/EG des Rates vom 14. Dezember 1998 zur Änderung der Richtlinien 66/400/EWG,

66/401/EWG, 66/402/EWG, 66/403/EWG, 69/208/EWG, 70/457/EWG und 70/458/EWG über denVerkehr mit Betarübensaatgut, Futterpflanzensaatgut, Getreidesaatgut, Pflanzkartoffeln, Saatgut vonÖl- und Faserpflanzen, Gemüsesaatgut und über den gemeinsamen Sortenkatalog fürlandwirtschaftliche Pflanzen, und zwar hinsichtlich der Konsolidierung des Binnenmarkts, genetischveränderter Sorten und pflanzengenetischer Ressourcen


Appendix 4: List of Interview Partners

Achaz, H., President, Gesellschaft Nierentransplantierter und Dialysepatienten Österreichs,Landesgruppe Wien, Niederösterreich und Burgenland

Aigner, G., BMAGS, (information over the telephone)

Bachmayer, H., Head of Research Department, Corporate Biosafety, Novartis Österreich

Baranyovski, H., Head of Staff, Novartis Forschungsinstitut GmbH

Bartik, MA 26, City of Vienna

Brosch, B., Head of Department, Section of Industry: Department of Food Industry Affairs,BMwA

Faber, F., Managing Director, ARGE für Gentechnik-frei erzeugte Lebensmittel

Fromwald, S., Expert in Gene Technology, Greenpeace Austria

Gaugitsch, H., Expert in Gene Technology, UBA – Federal Environment Agency

Geisler, E.P., Manager, Pharmig

Gold, G., Assistant of the Managing Director, AgrEvo Austria

Grüll, H., Responsible for Biotechnology, Zuckerforschung Tulln

Guenzburg, W. H., Head of the Institute, Institut für Virologie, VeterinärmedizinischeUniversität Wien

Hammerschmied, S., Manager, Impulse Programme Biotechnology

Hampel, W., Chairman, ÖGBT – Austrian Society for Biotechnology

Herlitschka, S., Head of Unit, BIT – Bureau for International Research and Technology, Cooperation Unit Life Sciences and Technology

Hinterholzer, J., Expert in Plant Variety Registration, BLF – Federal Agency and ResearchCenter for Agriculture

Jank, B., Expert in Biotechnology, Section VI, BKA/BMFV

Jedlicka, B., Responsible for the "Food Initiative", FFF – Austrian Industrial ResearchPromotion Fund

Kahnert, E., Gesellschaft Nierentransplantierter und Dialysepatienten Österreichs,Landesgruppe Wien, Niederösterreich und Burgenland

Katinger, H., Head of Institute, Institute for Applied Microbiology, BOKU

Kreijs, F. R., Manager, Horizonte Venture Management GmbH

Latzko, F., Head of the Professional Association, Professional Association of ChemicalIndustry of the WKÖ


Leitner, E., Head of Research & Development, Biochemie GmbH

Mandl, C., Institut für Virologie der Universität Wien, (information over the telephone)

Mantler, B. V., Public Relations, Nestle Austria

Mayrhofer, R., Head Press Department/Public Relations, Pharmig

Messner, K., Microbiologist, Institute for Biochemical Technology and Microbiology,University of Technology Vienna

Moldenhauer, H., Global 2000, (information over the telephone)

Moser, A., Head of Institute, Institut für Biotechnologie, Technische Universität Graz

Mühlbacher, F., Head of Institute, Univ.-Klinik für Chirurgie, AKH

Nohel, C., Economist, Culinar – Institute for Nutrition Culture

Pasterk, M., Responsible for Biomedical Research, BMWV

Raab, F., Director, Association of Austrian Plant Breeders

Rafetseder, O., Fonds Gesundes Österreich, (information over the telephone)

Rath, G., Responsible for Biotechnology, Knorr C H Food Industry

Rosian, I., Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG)

Rudolph, F., Manging Director, Pioneer Seeds

Sattler, A., Expert in Food Law, Section VI, BKA/BMFV

Sattler, L., Universität Wien

Schmidt, J., Head of the Department, Department of Biotechnology, Austrian ResearchCenter Seibersdorf

Schuster, G., BMFV, (information over the telephone)

Schwab, H., Professor, Institut für Biotechnologie, Technische Universität Graz

Sodeck, Manager, Firma Vogelbusch

Steiner, W., Professor, Institut für Biotechnologie, Technische Universität Graz

Steyskal, F., Managing Director, IFA Tulln – Inter-universitary Research Institute for Agro-biotechnology

Streicher, B., Co-ordinator of Public Relations, ÖGGGT – Austrian Society for Genetics andGene Technology

Svoboda, A., Co-ordintator of Public Relations, Ecker & Partner, PR Agency in Charge forPublic Relations for the "Forum Biotechnology"

Teufel, E., Responsible for the Topic Gene Technology, Kraft Jacobs Suchard Austria


Weigl, M., Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG)

Würzner, H., Expert in Feeding Stuff Economy, BLF – Federal Agency and Research Centerfor Agriculture

Zach, P., Expert in Seed Economy, BMLF


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Aiginger, K., Wieser, R., Wüger, M. (Hg.) (1999): Marktmacht im Einzelhandel,Österreichisches Institut für Wirtschaftsforschung, Wien.

ARGE Gentechnik-frei (1998). Broschüre.

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Data Sources

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EUROSTAT (2000): Eurostat Jahrbuch 2000. Europa im Blick der Statistik. Daten aus denJahren 1988-1998.

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SNIF 2000: Summary Notification and Information Format. http://food.jrc.it/gmo/, last update2000-01-10.

Statistik Österreich, www.oestat.gv.at.

Newspapers and Press Reports

APA – Austria Presse Agentur – Austria Press Agency

APA/OTS – Austria Press Agency/ original text of the sender which is exclusively responsiblefor the content

Daily Newspapers: Der Standard, Die Presse, Neue Kronen Zeitung


Appendix 6: List of Abbreviations

AK Chamber of Labour – Kammer für Arbeiter und Angestellte

AMG Austrian Drug Law – Arzneimittelgesetz

APA Austria Press Agency – Austria Presse Agentur

APA/OTS Austria Press Agency/Original Text of the Sender which is exclusively responsible forthe content

ARCS Austrian Research Center Seibersdorf – Österreichisches ForschungszentrumSeibersdorf

ATS Austrian Shilling

BINGO Business Interest Non-Governmental Organisation

BIT Bureau for International Research and Technology Cooperation – Büro fürInternationale Forschungs- und Technologiekooperation

BKA Federal Chancellory – Bundeskanzleramt

BKA/BMFV Federal Chancellery/Federal Minister for Women's Affairs and Consumer Protection– Bundeskanzleramt/Bundesministerin für Frauenangelegenheiten undVerbraucherschutz

BLF Federal Agency and Research Center for Agriculture – Bundesamt undForschungszentrum Landwirtschaft

BLMUF Federal Institution for Food Examination and Research – Bundesanstalt fürLebensmitteluntersuchung und -forschung

BMAGS Federal Ministry of Labour, Health and Social Affairs – Bundesministerium für Arbeit,Gesundheit und Soziales

BMBWK Federal Ministry for Education, Science and Culture – Bundesministerium für Bildung,Wissenschaft und Kultur (since April 2000)

BMWFK Federal Ministry of Science, Research and Arts – Bundesministerium fürWissenschaft, Forschung und Kunst (1994 until April 2000)

BMFV see BKA/BMFV

BMGSK Federal Ministry for Health, Sports and Consumer Protection – Bundesministerum fürGesundheit, Sport und Konsumentenschutz (until 1997)

BMI Federal Ministry for Interior – Bundesministerium für Inneres

BMLF Federal Ministry for Agriculture and Forestry – Bundesministerium für Land- undForstwirtschaft

BMLFUW Federal Ministry of Agriculture, Forestry, Environment and Water-Management –Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft (sinceApril 2000)

BMÖWV Federal Ministry for Public Economy and Traffic – Bundesministerium für öffentlicheWirtschaft und Verkehr (until 1994)

BMSG Federal Ministry for Social Security and Generations – Bundesministerium für sozialeSicherheit und Generationen (since April 2000)

BMUJF Federal Ministry for Environment, Youth and Family – Bundesministerium für Umwelt,Jugend und Familie

BMwA Federal Ministry of Economic Affairs – Bundesministerium für wirtschaftlicheAngelegenheiten


BMWF Federal Ministry of Science and Research – Bundeministerium für Wissenschaft undForschung (until 1994)

BMT Competence Center for Biomolecular Therapeutics – BiomolekularesTherapiezentrum

BMWV Federal Ministry of Science and Transport – Bundesministerium für Wissenschaft undVerkehr

BOKU University of Agriculture in Vienna – Universität für Bodenkultur in Wien

CAP (European) Common Agricultural Policy

ELSA Ethical, Legal and Social Aspects (in Genomes Research)

EMEA European Agency for the Evaluation of Medical Products

EPC European Patent Convention

EPIDOS European Patent Information and Documentation Office

EPO European Patent Office

ERP- Fonds European Recovery Programme Fonds

ESA European System of Accounts

EuCJ European Court of Justice

EVCA European Private Equity and Venture Capital Association

FAIR Fisheries and Agriculture (including Agro-Industry, Food Technologies, Forestry andRural Development)

FFF Austrian Industrial Research Promotion Fund – (Österreichischer)Forschungsföderungsfonds für die gewerbliche Wirtschaft

FP4 Fourth Framework Programme

FPÖ Freedom Party – Freiheitliche Partei Österreichs

FTFG Science and Technology Promotion Act – Forschungs- undTechnologieförderungsgesetz

FWF Austrian Science Fund – (Österreichischer)Fonds zur Förderung derwissenschaftlichen Forschung

GDP Gross Domestic Product

GERD Gross Expenditure on Research and Development

GMO Genetically Modified organism

GT Gene Technology

GTG Gene Technology Act – Gentechnikgesetz

IAM Institute for Applied Microbiology at the University of Agriculture in Vienna

IFA-Tulln Inter-Universitary Research Institute for Agro-Biotechnology Tulln – InteruniversitäresForschungsinstitut für Agrobiotechnologie Tulln

IMAS Institute for Market and Social Analysis – Institut für Markt- und Sozialanalysen

IMP Institute for Molecular Pathology – Institut für Molekulare Pathologie

INFOGen Information Bureau for Gene Technology – Informationsstelle für Gentechnologie

IPB Impulse Programme Biotechnology – Impulsprogramm Biotechnologie

IPR Intellectual Property Rights

ITA Institute for Technology Assessment at the Austrian Academy of Sciencies – Institut fürTechnikofolgenabschätzung an der österreichischen Akademie der Wissenschaften

ITF Innovation and Technology Fund – Innovations- und Technologie Fonds


IV Federation of Austrian Industry – (Österreichische) Industriellenvereinigung

LBG Ludwig Boltzmann-Society – Ludwig Boltzmann-Gesellschaft

LBI Ludwig Boltzmann-Institute – Ludwig Boltzmann Institut

LF / LIF Liberal Forum/Liberal Party – Liberales Forum

NBT Non-Biotechnology

NGO Non-Governmental Organisation

NSI National System of Innovation

NURO Non-University Research Organisation

OBT Other Biotechnology

ÖBIG Austrian Federal Institute for Health Care – Österreichisches Bundesinstitut fürGesundheitswesen

ÖGBT Austrian Society for Biotechnology – Österreichische Gesellschaft für Biotechnologie

ÖGGGT Austrian Society for Genetics and Gene Technology – Österreichische Gesellschaft fürGenetik und Gentechnik

ÖGNU Austrian Society for Nature and Environmental Protection – ÖsterreichischeGesellschaft für Natur- und Umweltschutz

ÖNB (OENB) Austrian National Bank – Österreichische Nationalbank

ÖPUL Austrian Programme for Environment and Agriculture – Österreichisches Programmfür Umwelt und Landwirtschaft

ÖSTAT Austrian Central Statistics Office – Österreichisches Statistisches Zentralamt

ÖVP People's Party – Österreichische Volkspartei

PatG (Austrian) Patent Law – (Österreichisches) Patentgesetz

PCR Polymerase Chain Reaction

Pharmig Austrian Association of Pharmaceutical Companies

PINGO Public Interest Non-Governmental Organisation

PPP Purchase Power Parity

PSR Public Sector Research

R & D Research and Development

RFTE Council for Research and Technological Development – Rat für Forschung undTechnologieentwicklung

SNIF Summary Notification and Information Format

SPÖ Austrian Social Democrat Party – Sozialdemokratische Partei Österreichs

SPR Special Research Programmes

SSI Sectoral System of Innovation

TAB Bureau for Technology Assessment at the German Parliament – Büro fürTechnikfolgenabschätzung beim Deutschen Bundestag

Tecma Technology Marketing Austria

TLO Technology Licencing Office

TVG Law Animal Experiments – Tierversuchsgesetz

UBA Federal Environment Agency – Umweltbundesamt

VBC Vienna Bio-Centre

WKÖ Austrian Federal Economic Chamber – Wirtschaftskammer Österreich

WWF World Widlife Fund

european biotechnology innovation system (ebis)€¦ · european biotechnology innovation system...

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